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The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows: • Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time. The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.

The subject Sterilization Pouch and Roll device has five types: (1) Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam. (2) Sterilization pouches, Flat: These pouches have the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using. (3) Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height. (4) Sterilization rolls, Flat: These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches. (5) Sterilization rolls, Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height. The Sterilization pouch and roll is composed of medical grade paper (60g/m2) and medical compound film (52μm), it is intended to be used to contain medical devices to be terminally sterilized by the Steam sterilization process. The recommended sterilization cycle parameters are: Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months. The Pouch/Roll is printed with a chemical indicator bar that changes from Blue to Dark grey when exposed to steam during the sterilization process. The steam chemical Indicator offers an addition way to verity processing in the sterilization cycle. The endpoint stability of the chemical indicator color change to dark grey is 3 months. The chemical Indicator should be used in addition to, not in place of, the biological indicator. The steam chemical indicator does not signify sterilization; it only indicates that the indicator has been exposed to steam.

GCI Sterilization Wrappers are intended to be used to enclose reusable textile-based medical devices, such as surgical gowns, towels, and drapes, for sterilization by a health care provider. They are designed to allow effective steam sterilization of the enclosed textile items and to maintain sterility until use, for up to 28 days. GCI Sterilization Wrapper sizes and validated load limitations are as follows: | SKU / Model | Size | Border Color | Maximum Validated Load Weight | |---|---|---|---| | P81818 KBRO | 18"x18" | White | 1 lbs | | P82424 KBRO | 24"x24" | Pink | 1.82 lbs | | P83030 KBRO | 30"x30" | Yellow | 3.45 lbs | | P83636 KBRO | 36"x36" | Blue | 5.8 lbs | | P84545 KBRO | 45"x45" | Mint | 10.98 lbs | | P85454 KBRO | 54"x54" | Red | 18.5 lbs | | P86060 KBRO | 60"x60" | Green | 25 lbs | GCI Sterilization Wrappers are reusable through 38 wash, dry, and sterilization cycles. Pack assembly should follow established folding, assembly, and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. Closure can include autoclave tape and elastomer closures. Sterilization: A prevacuum steam sterilization cycle (4 minutes exposure at 132°C, Dry Time: 30 minutes) has been validated.

GCI Sterilization Wrappers are intended to enclose a textile-based medical device for sterilization and maintain sterility of the enclosed device until used. The proposed devices are medical devices that are provided non-sterile. They may be reused up to 38 times. They are available in multiple sizes to accommodate textile-based medical devices, ranging from 18"x18" to 60"x60". The size is indicated by color coding of the wrap borders for easy identification. Load sizes should be large enough to prevent too much overlapping of the wrapper material (such that all but one side of the wrapper should be a single layer when properly folded) to allow appropriate sterilant penetration. Load sizes should be small enough to overlap by at least 2 inches on the remaining side to ensure there are no gaps.

The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The recommended sterilization cycles are as follows: • Steam Sterilization: 4 minutes at 132°C (270°F); 10 minutes dry time for gauze and plastic loads, and 20 minutes dry time for metal loads. • Ethylene Oxide (ETO) Sterilization: 8 hours at 50°C (122°F); relative humidity between 30%-90%; ethylene oxide concentration is 700mg/L, 7 days aeration time at 23°C(73.5°F). The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch maintains the sterility of the enclosed devices for up to 6 months post Steam or ETO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark green after sterilization.

The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process.

The Turbett Surgical Instrument Pod is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with Turbett Surgical Filters. The unit is intended to be used in a pre-vacuum steam sterilizers with a pre-vacuum cycle of 270°F (132°C) and exposure time of 4 minutes. - The TS1500 Container may be loaded to a maximum weight of 375 lbs., not to exceed 25 lbs. in any tray. Minimum drying time for loads up to 140lbs. is 10 minutes, for loads up to 375 lbs. is 30 minutes. - The TS1200 Container may be loaded to a maximum weight of 300 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes for loads up to120 lbs. and 30 minutes for loads up to 300 lbs. - The TS1000 Container may be loaded to a maximum weight of 100 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes. - The system was validated with 0.7 mm x 500 mm and 1.0 mm x 850 mm rigid and flexible lumens. Use only uncovered, perforated, or wire mesh general delivery trays within the Turbett Surgical Instrument Pod.

The Turbett Surgical Instrument Pod is a multi-tray rigid sterilization container with a fenestrated door holding a single use filter. The container is designed to be used in a steam autoclave and hold multiple open trays containing surgical instruments. Unwrapped, uncovered, perforated sterilization trays are stacked into the container, separated by anodized aluminum dividers, which allow steam to evenly penetrate and allow condensation to drain. The container is manufactured from 304 stainless steel sheet metal and bar stock. The container is sealed on all sides except one which is the door / filter panel. The single fenestrated door consists of two perforated anodized aluminum panels which cover the exposed container side wall. A custom-made disposable filter consisting of 2 layers of filter paper separated by a layer of compressible single-use gasket material is placed between the two perforated metal panels of the door. Spring loaded latches compress the anodized aluminum door frame with filter assembly to the container for a secure seal. The Turbett Surgical Instrument Pod is loaded into the auto clave with a dedicated transfer mechanism and cart.

The Sterilization Package/Reel is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 minutes. · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃(140°F). Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process. The Sterilization Package/Reel is offered 3 types in the following: Self -Seal Sterilization Pouch; Flat Sterilization Reel; Gusseted Sterilization Reel.

The medical devices are inserted into the Sterilization Package/Reel,sealed, and then sterilized. After completion of the sterilization process, the Pouch/Roll main- tains the sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post Steam or EO gas sterilization. The Self-seal Sterilization Package permits the sealing of the pouch without the need of heat-sealing equipment, while the Heat-Seal Sterilization Reel are heat-sealed prior to processing in the steam/or EO Sterilization. The chemical indicators ink printed on the "medical dialysis paper" will exhibit a color change after the Package/Reel is exposed to steam or ethylene oxide gas. The color of the Chemical Indicator changes from blue to black when exposed to Steam. And the color changes from pink to yellow, when exposed to EO gas. The Chemical Indicator which is Type 1 Process Indicator as categorized by ISO 11140-1:2014 offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows: a) Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 ℃ (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F). The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture. The pouch's external chemical indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)

The Sterilization Pouches and Reels is composed of medical compound film. It is intended to be used to contain medical devices to be terminally sterilized by Steam or EO sterilization process. The recommended sterilization cycle parameters are as follows: - Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. a) - b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F). The medical devices are inserted into the Pouches/Reels, and then sterilized for the EO or Steam Sterilization Process. The heat-sealed Pouches/Reels are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouches/Reels maintain sterility of the enclosed medical devices until the seal is opened. The Sterilization Pouches and Reels maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture. The Sterilization Pouches and Reels is printed with chemical indicator bars that changed from Pink to Cocoa(Steam) or Blue to Golden Brown (EO) when exposed to steam vapor or EO gas during process. The steam and EO chemical indicator offer an addition way to verify processing in the sterilization cycle. The chemical indicator should be used in addition to, not in place of, the biological indicator. The steam and EO chemical indicators do not signify sterilization; they only indicate that the indicators have been exposed to the Steam or EO.

The Medicom Sterilization Pouch and Reel are intended to provide health care workers with an effective method to enclose devices, and they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: - · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes. - Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. - · Pre-vacuum steam at 134°C (273°F) for 4 minutes; Drying time of 20 minutes. - · Ethylene Oxide (EO) with a concentration of 600 mg/L at 50°C (122°F) and 60% to 85% relative humidity for 120 minutes. Single Pouch: Aeration time of 5 days at 25°C (77°F). Double Pouches: Aeration time of 3 days at 25°C (77°F). Furthermore, there are 3 thicknesses for health care workers to choose from as follows: - · Pouch of Combination A: Medical grade paper 60g+laminated film 44/m - Pouch of Combination B: Medical grade paper 60g+laminated film 52um - · Pouch of Combination C: Medical grade paper 70g+laminated film 52um The Medicom Sterilization Pouch and Reel which are made with Paper maintains the sterility of the enclosed devices for up to 1 year post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The medical devices are inserted into the Medicom Sterilization Pouch and Reel, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Reel maintains the sterility of the enclosed medical devices until the seal is opened. And they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The device is intended to allow the sterilization of enclosed devices and maintain sterility for the enclosed devices until used up to 1-year post-steam or EO gas sterilization. The Self-seal pouch permits the sealing of the pouch without heat-sealing equipment, while the heat-sealed pouches and reels are heat-sealed before processing in the steam/or EO Sterilization. The chemical indicators printed on the "medical grade paper" will exhibit color change after the pouch is exposed to steam or ethylene oxide gas. The "Medicom Sterilization Pouch and Reel" is printed with dual chemical indicators that the color change from Red/Pink to Cocoa when exposed to Steam, and the color changes from Blue to Golden Yellow /Brown, when exposed to EO gas. The Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, but not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas. Furthermore, there are 3 thicknesses with dimensions for health care workers to choose from as follows: - Pouch of Combination A: Medical grade paper 60g+laminated film 44um Dimensions of 880 series: W: 57mm ~ 415mm; L: 127mm~727mm Dimensions of 870 series: W: 89mm ~ 457mm; L: 159mm~635mm Dimensions of 95 series: W: 50mm ~ 250mm; L: ~30.5M - Pouch of Combination B: Medical grade paper 60g+laminated film 52um Dimensions of 881 series: W: 57mm ~ 381mm; L: 127mm~797mm Dimensions of 871 series: W: 89mm ~ 457mm; L: 159mm~559mm Dimensions of 951 series: W: 50mm ~ 250mm; L: ~200M - · Pouch of Combination C: Medical grade paper 70g+laminated film 52um Dimensions of 882 series: W: 57mm ~ 381mm; L: 127mm~797mm Dimensions of 872 series: W: 89mm ~ 457mm; L: 159mm~559mm Dimensions of 952 series: W: 50mm ~ 250mm; L: ~200M

CDB Hospital ® Sterilization Wraps intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: · Pre-vacuum Steam 270°F/132°C for 4 minutes · Advanced Sterilization Products (ASP) STERRAD® 100S · Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles) • STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles) The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used. Pre-Vacuum Steam Sterilization: - · Validated for dry time of 30 minutes for 44gsm. - · Validated for dry time of 30 minutes for 70gsm. - · Validated maximum weight of 6 lbs for 44 gsm. - · Validated maximum weight of 15 lbs for 70 gsm. • All models of CDB Hospital ® Sterilization Wraps validated for pre-vacuum steam sterilization with stainless steel lumens of 3 mm diameter or larger and length 400 mm or shorter as part of the load. Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization: All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100S sterilization with stainless steel lumens as part of the load with a maximum weight of 10.7lbs. Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization: All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100NX sterilization cycles are detailed below: VALIDATED ADVANCED STERILIZATION PRODUCTS (ASP) STERRAD® 100NX CYCLES Advanced Sterilization Products (ASP) STERRAD® System and Cycle Intended Load for 100NX Standard Cycle: Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: · An inside diameter of 0.7mm or larger and a length of 200mm or shorter of single channel stainless steel lumens. Intended Load for 100NX Flex Cycle: One or two single-channel flexible endoscopes with or without a silicone mat. Flexible endoscope may contain: A single channel Teflon/PE/PTFE lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter (a maximum of two flexible endoscopes, one per tray per sterilization cycle). Intended Load for 100NX Express Cycle: Non-lumened reusable metal and non-metal medical devices requiring surface sterilization, or sterilization of mated stainless steel and titanium surfaces, and rigid or semi-rigid endoscopes without lumens. STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems: • All models of CDB Hospital® Sterilization Wraps have been validated for use with STERIS V-PRO® cycles detailed below. · CDB Hospital® Sterilization Wraps were validated to be effectively aerated during the preprogrammed STERIS Amsco V-PRO® Sterilization Cycles. VALIDATED STERIS AMSCO® V-PRO CYCLES STERIS Amsco® V-PRO Cycle Intended Load for Lumen Cycle: Reusable metal and non-metal medical devices, including up to 20 stainless steel lumens with dimensions of 3.0mm diameter or larger and a length of 400mm or shorter. Intended Load for Non Lumen Cycle: Non lumened reusable metal and non-metal medical devices. Intended Load for Flexible Cycle: Single lumen surgical flexible endoscopes and bronchoscopes in the following load configuration: 1.) One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat. The flexible endoscope having an inside diameter of 3 mm or larger and a length of 450 mm or shorter. 2.) An additional tray containing non-lumened medical devices.

The CDB Hospital ® Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The CDB Hospital ® Sterilization Wraps' SMS fabric is made of 100% polypropylene, blue color, and are separated into two distinct product offerings: CDB Hospital® Sterilization Wraps, 44gsm: Consist of two sheets of SMS wrap (light blue and dark blue), ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard health care practices. CDB Hospital® Sterilization Wraps, 70gsm: Consist of two sheets of SMS wrap (light blue and dark blue), ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices. CDB Hospital® Sterilization Wraps are composed of polypropylene with the addition of light blue and dark blue pigment and an antistatic treatment. The CDB Hospital ® Sterilization Wraps allow a sterilized package of medical devices to be opened aseptically. This product is over-the-counter use.

Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using: - · Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time - Pre-vacuum steam at 132℃ (270°F) for 4 minutes; 20 minutes dry time - · Pre-vacuum steam at 134℃ (273°F) for 3 minutes; 20 minutes dry time - Pre-vacuum steam at 135℃ (275°F) for 3 minutes; 16 minutes dry time - Ethylene Oxide (EO) with a concentration of 735 mg/L at 55℃ (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F). - The recommended hydrogen peroxide vapor sterilization cycle is : - · Standard Cycle of STERRAD® 100S - Standard cycle and Advanced cycle of STERRAD® NX - · Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX - · Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX The steam and EO device are not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen listed below: - Standard Cycle of STERRAD® 100S - inside diameter ≥ 1 mm and length ≤ 125 mm - inside diameter ≥ 2 mm and length ≤ 250 mm - Standard cycle of STERRAD® NX - · Single channel stainless steel lumens with: - Inside diameter ≥ 1 mm and length ≤ 150 mm - Inside diameter ≥ 2 mm and length ≤ 400 mm - · Single channel PE/PTFE tubing with: - Inside diameter ≥ 1 mm and length ≤ 350 mm - Advanced cycle of STERRAD® NX - · Single channel stainless steel lumens with: - Inside diameter ≥ 1 mm and length ≤ 500 mm - · Single PTFE lumen tubing with: - Inside diameter ≥ 1 mm and length ≤ 1000 mm - · Single channel PE/PTFE flexible endoscopes with: - Inside diameter ≥ 1 mm and length ≤ 850 mm - Standard cycle of STERRAD® 100NX - · Single channel stainless steel lumens with: - Inside diameter ≥ 0.7 mm and length ≤ 500 mm - Single channel PE/PTFE instruments with: - Inside diameter ≥ 1 mm and length ≤ 1000 mm - Flex cycle of STERRAD® 100NX - Single channel PE/PTFE flexible endoscope with: - Inside diameter ≥ 1 mm and length ≤ 850 mm - Lumen Cycle of V-PRO® maX △ Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. △ Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: - Single channeled devices with a stainless lumen that is > 0.77mm internal diameter (ID) and < 500mm in length - Dual channeled devices with stainless steel lumens that are ≥ 0.77mm ID and ≤ 527mm in length - · Triple channeled devices with stainless steel lumens that are - ≥1.2 mm ID and ≤ 275 mm in length - ≥1.8 mm ID and ≤ 310 mm in length - Or - ≥2.8 mm ID and ≤ 317 mm in length - Flexible Cycle of V-PRO® maX △ Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load. The flexible endoscopes may contain either: - · A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length - · Or two lumens with: - One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length - △ One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. The flexible endoscopes my contain either: ● A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length - Or two lumens with: - One lumen that is ≥ 1 mm ID and ≤ 990 mm in length - And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam, EO, or hydrogen peroxide sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple or from Pink to Cocoa after exposure to steam, from yellow to brown or from Blue to Brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide. The paper version of the pouch is for Steam and EO. The Tyvek version of the pouch is for hydrogen peroxide sterilization only. If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years(for paper pouch) and 2 years(for Tyvek pouch) from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 12 months after steam sterilization and 24 months after EO sterilization(for paper pouch), and, 2 years after hydrogen peroxide sterilization (for Tyvek Pouch). The maximum validated pouch load is 2.64 pounds (1.2kg).

The device is made from porous material printed chemical indicator thermally sealed to a plastic film, additionally Self-Seal has medical double side tape. They are divided according to porous material to paper pouch and Tyvek pouch. Paper Pouch are constructed from uncoated medical paper and plastic film; it can be used with steam and EO sterilization. Tyvek Pouch are constructed from an uncoated Tyvek and plastic film, , it can be used with hydrogen peroxide sterilization. The device is preformed sterile barrier systems, sealed 2 sides (roll for left and right) or 3 sides(pouch for left, right and top). The remaining edges can be Heat-Sealed or Self-Sealed to form a sealing system. The Self-Seal pouch permits sealing of the pouch without Heat-Sealing equipment, whereas the Heat-Sealable pouches must be Heat-Sealed prior to the cycle. The pouches and rolls are used to enclose medical devices that are to be sterilized by a healthcare provider following manufacturer's instructions. The medical devices are inserted into Pouches or rolls and sealed. The devices contain chemical process indicator intended to demonstrate that the device has been exposed to the steam, EO and vapor hydrogen peroxide Sterilization.

The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following: - Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600. - 100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C. - Lumen. Non-Lumen. and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems. - Advanced Sterilization Products STERRAD 100S system - Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle] - Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle] PRIMED Sterilization wraps are available in 6 models and different sizes ranging from 12" X 12" to 54" X 90" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) for a maximum of 180 days or until used. PRIMED Sterilization wraps are validated for use with above listed sterilization systems with the intended loads as described below.

The PRIMED Sterilization wraps are made of SMS (Spunbond) Polypropylene with addition of a master batch pigment for coloration and are available in three separate product offerings: - 1- The Fused one colour double layer bonded wrap is comprised of two sheets ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices. - 2- The Fused two colours double layer bonded wrap is comprised of two sheets of purple and blue fabrics ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple or blue pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices. - 3-The Single layer one colour wrap is comprised of a single nonwoven sheet. The standard purple wrap is composed of polypropylene with the addition of a purple pigment. Two sheets are used to sequentially wrap medical devices to be sterilized in accordance with standard healthcare practices. PRIMED Sterilization wraps are available in various dimensions ranging from 12″ x 12″ x 90″ and six different weights as detailed in table 1.