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Unistik® ShieldLock: The Unistik ShieldLock Blood Collection Set is a sterile, multi-sample, single-use "butterfly" style blood collection set intended to be used by trained healthcare professionals for venipuncture to obtain blood specimens from patients into blood collection tubes or blood culture bottles. When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe. Unistik® VacuFlip: The Unistik VacuFlip Safety Blood Collection Needle is intended to be used by healthcare professionals with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Unistik® ShieldLock is a sterile, single use, multi-sample blood collection set for use by healthcare professionals to obtain venous blood specimens from patients when used in conjunction with blood collection tubes or syringes. The Unistik Shield Lock is a 'butterfly needle' with wings, the color of the wings is unique for each needle gauge to assist with identification. The Unistik ShieldLock is designed for prescription use only and is to be used only by healthcare professionals for patients who are required to have venous blood specimens collected. The Unistik® VacuFlip is a sterile, single use, multi-sample blood collection vacuum needle for use by healthcare professionals to obtain venous blood specimens from patients when used in conjunction with blood collection tubes or syringes. The Unistik VacuFlip is a 'vacuum needle' and is designed with a user activated integral sharps injury prevention feature, the safety shield, which can be activated after the needle is removed from the vein to help prevent needlestick injuries. The safety shield features a textured surface to help improve grip during activation. An audible click signals that the safety shield is activated and is locked in place, covering the needle, and preventing reuse. The color of the safety shield is unique for each needle gauge to assist with identification. The Unistik VacuFlip is designed for prescription use only and is to be used only by healthcare professionals for patients who are required to have venous blood specimens collected.

Unistik® Heelstik: The Unistik® Heelstik heel incision safety lancets are single use devices used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers. Unistik® TinyTouch: The Unistik® TinyTouch heel incision safety lancets are single used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers.

The submission devices are sterile single-use devices with integral sharps protection whereby the lancet blade or needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. The devices automatically self-disable after a single use, thus preventing any hazards of re-use. The submission devices are intended for use by healthcare professionals only, for performing heel incisions on newborns, preemies, and toddlers to obtain capillary blood specimens for IVD assays. The product is intended for prescription (Rx) only use.

The intended user is any patient that needs to obtain capillary samples at home/clinical environment. Unistik Pro is a single-use lancet used to obtain a capillary blood sample.

The Unistik® Pro is a sterile single-use safety lancet, a hand-held disposable device intended to be used to achieve a controlled skin puncture on the fingertip, in order to obtain a capillary blood specimen. The Unistik® Pro sterile single-use safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.q., for blood glucose monitoring in patients with diabetes, The Unistik® Pro safety lancets are available in 3 different variants, each with a different needle gauge (21G, 25G and 28G with penetration depths of 2.0mm, 1.6mm and 1.2mm respectively) as required by the patient. The Unistik® Pro sterile single-use safety lancets are designed for prescription and over-thecounter use and to be used by self-testing patients, care-givers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the finqertip, in order for caregivers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female, right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime. The Unistik® Pro sterile single-use safety lancets feature integral sharps protection whereby the lancet needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the device automatically self-disables after a single use, thus preventing any hazards of re-use.

Freestyle Lancing Device II: Use with compatible lancets for capillary blood sampling. Autolet: Use with compatible lancets for capillary blood sampling. Autolet Lite: Use with compatible lancets for capillary blood sampling. Unilet Lancets: Use with compatible lancing device for capillary blood sampling.

The FS & A Device is a hand-held non-sterile, reusable lancing device intended for single patient capillary blood sampling in non-clinical environments. The ADC Freestyle Lancing Device II variant is sold for use with ADC 'Freestyle' single-use lancets; these are not included in this submission. The OM Autolet variant is sold for use with Unilet Lancets and as 'universally compatible with most lancets'. The lancets are disposed of after each use and the device is maintained by using isopropyl alcohol or soap to wipe the outside of the device. The FS & A Device is for use only on a single patient. The Autolet Lite is a hand-held non-sterile, reusable lancing device intended for single patient capillary blood sampling in non-clinical environments. The device was designed for use as a system with Unilet Lancets (and as 'universally compatible with most lancets') which are included in this 510(k) The Unilet Lancets feature 3 lancet gauges, 3 with labelling "Unilet Lancets" and the same 3 lancet gauges labelled "Unilet ComforTouch Lancets". These lancets have different gauge sizes and styling but are functionally identical and for the purpose of this 510(k), all references to "Unilet Lancets" can be considered to apply to Unilet Lancets and Unilet ComforTouch Lancets.

The Unistik® Touch is a puncture device to obtain micro blood samples. Unistik Touch has a sharps prevention feature to protect the user from a needlestick injury.

The Unistik® Touch contact-activated safety lancets are hand-held disposable devices intended for performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism. Unistik® Touch safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.g. for blood glucose monitoring in patients with diabetes. The Unistik® Touch contact-activated safety lancets are available in five different variants of needle gauge as follows: Needle gauge 16G, Penetration Depth 2.0 mm Needle gauge 21G, Penetration Depth 2.0 mm Needle gauge 23G, Penetration Depth 2.0 mm Needle gauge 28G, Penetration Depth 1.8 mm Needle gauge 30G, Penetration Depth 1.5 mm The Unistik® Touch contact-activated safety lancets are intended for prescription and over-the-counter use and to be used by self-testing patients, care-givers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for caregivers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female. right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime. Unistik® Touch contact-activated safety lancets are sterile single-use devices with integral sharps protection whereby the lancet blade or needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the devices automatically self-disable after a single use, thus preventing any hazards of re-use. The Unistik® Touch contact-activated safety lancets achieve their intended purpose of performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism with a pre-loaded steel spring for propelling the lancet holder forward when the device is activated and subsequently automatically retracting it. After retraction, the lancet holder is automatically locked into the device such that the device cannot be re-used and the needle tip is safely shielded. The lancet needles are moulded into the lancet holder component such that the needle tip is sealed by complete encapsulation in overmoulded plastic. The complete lancet holder component is then sterilised by gamma irradiation, so after irradiation the sterility of the needle tip is maintained by encapsulation within the plastic. The sterile seal is only broken when the user twists off and removes the lancet cap immediately before use. The needle tip is the exposed needle length after the cap is removed, and this is the only part of the needle that will penetrate the patient's skin during use. Therefore, the encapsulation of the needle tip by plastic overmoulding performs the function of primary packaging, whereby a sterile seal is maintained until the point of use.

The single-use safety lancets are hand-held disposable devices intended to achieve a controlled skin puncture, typically on the fingertip, to obtain a capillary blood specimen.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are hand-held disposable devices intended to be used to achieve a controlled skin puncture on the fingertip, in order to obtain a capillary blood specimen. The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.g. for blood glucose monitoring in patients with diabetes. The Unistik® 3 safety lancets are available in five different variants, each with a different needle gauge (18G, 21G, 23G, 28G, 30G) to facilitate appropriate blood flow rates from the skin puncture. There are two high flow variants (18G, 21G) one medium flow variant (23G) and two low flow variants (28G, 30G). The Unistik® 3 Value devices are identical to the equivalent gauge of Unistik® 3 devices, except for the colour of the plastic body housings. The Unistik® 3 Value devices all have a vanilla body housing colour, whereas the Unistik® 3 devices have a different colour for each gauge. The Abbott SF sterile single-use safety lancets are available in a single configuration only (28G needle). The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are designed for prescription and over-the-counter use and to be used by self-testing patients, caregivers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for care-givers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female, right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime. The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are sterile single-use devices with integral sharps protection whereby the lancet needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the device automatically self-disables after a single use, thus preventing any hazards of re-use. The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are used by first twisting off the end cap, the needle tip is then exposed but remains safely shielded within the device housing. The user then presses the end face of the device against the sampling site, then activates the device by pressing the release button on the side of the lancet needle is then automatically propelled forward by the internal pre-loaded spring to lance the skin and also automatically retracted by the spring back inside the device housing, where it is then automatically locked to prevent re-use. After firing, the locked position of the needle tip inside the device ensures that it remains safely shielded, and the device can be safely disposed of into an appropriate sharps receptacle. The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets consist of a stainless steel lancet needle moulded into a plastic lancet holder component. which in turn is assembled into a moulded plastic outer housing with a pre-loaded steel spring for propelling the lancet holder forward when the device is activated and subsequently automatically retracting it. After retraction, the lancet holder is automatically locked into the device such that the device cannot be re-used and the needle tip is safely shielded. The lancet needles are moulded into the lancet holder component such that the needle tip is sealed by complete encapsulation in overmoulded plastic. The complete lancet holder component is then sterilised by gamma irradiation, so after irradiation the sterility of the needle tip is maintained by encapsulation within the plastic. The sterile seal is only broken when the user twists off and removes the lancet cap immediately before use. The needle tip is the exposed needle length after the cap is removed, and this is the only part of the needle that will penetrate the patient's skin during use. Therefore, the encapsulation of the needle tip by plastic overmoulding performs the function of primary packaging, whereby a sterile seal is maintained until the point of use.

The Unifine SafeControl™ range of pen needles are intended for use with multi-dose injection devices for the subcutaneous injection of FDA approved drugs, including insulin.

The Unifine SafeControl™ safety pen needle is a sterile, single-use, disposable device intended for use with multi-dose Injector devices for the subcutaneous injection of FDA approved drugs, including insulin. The device is designed for prescription and overthe-counter use and to be used by self-administering patients, caregivers and healthcare professionals. The safety pen needle is currently available in 30-gauge size with 5mm and 8mm lengths. The pen needle assembly consists of a cannula attached to a needle carrier assembled into a plastic moulded needle hub and safety guard, a primary container that houses the entire assembly and a sterility seal that covers the assembly inside the primary container. The entire device is packaged and labelled as a sterile singleuse device. The purpose of this Special 510(k) Premarket Notification is to increase the range of Unifine SafeControl™ safety pen needle devices to include qauge sizes of 31G and 32G in 4, 5, 6, and 8mm lengths.

The Unifine SafeControl™ range of pen needles are intended for use with multi-dose injection devices for the subcutaneous injection of FDA approved drugs, including insulin.

The Unifine SafeControl™ safety pen needle is a sterile, single-use, disposable device intended for use with multi-dose Injector devices for the subcutaneous injection of FDA approved drugs, including insulin. The device is designed for prescription and over-the-counter use and to be used by self-administering patients, care-givers and healthcare professionals. The safety pen needle is a 30-gauge needle available in sizes between 5mm and 8mm lengths. The pen needle assembly consists of a cannula attached to a needle carrier assembled into a plastic moulded needle hub and safety guard, a primary container that houses the entire assembly and a sterility seal that covers the assembly inside the primary container. The entire device is packaged and labeled as a sterile single-use device.

The Unifine Pentips range of pen needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin.

Unifine® Pentips® and Unifine® Pentips® Plus are sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. The pen needles are used by consumers, caregivers, and healthcare professionals. They are available in a variety of lengths (4mm, 5mm, 6mm, 8mm and12mm) and gauges (29G, 31G and 32G). The pen needle assembly consists of a double-ended cannula, a needle hub, a needle shield, primary container and sterility seal that covers the assembly inside the primary container. The hub has internal threads, which allows the pen needle to be screwed onto a pen injector device. The Non Patient (NP) end of the cannula (inside the hub) penetrates the rubber septum of the cartridge in the pen injector device. The Patient end and NP end of the cannula are lubricated using a silicone based lubricant to aid in injection and penetration into the rubber septum. The inner needle shield is injection molded and assembled over the Patient end of the needle to protect the needle from damage and accidental needle-sticks. The pen needle assembly is then inserted into an iniection molded outer container and sealed with a protective peel-away label to ensure a sterility barrier and tamper evidence. The outer container can be used to remove the hub with cannula from the pen injector device after the injection is completed. The peel-away label is pre-printed with information, which includes the lot number, expiry date, and size (length) and gauge of the needle. The individual needle assemblies are then packaged in bags and/or cartons, and placed into shippers with appropriate labeling. The shipper cases are then placed on pallets for sterilization. Unifine Pentips Plus pen needles differ from Unifine Pentips pen needles because the primary container consists of two 'chamber contains a new, unused pen needle and the second chamber is empty. The empty chamber serves as a built-in pen needle remover, and may prevent accidental needlesticks. Users can insert their used needle into the chamber, then unscrew from the injection pen. The primary container is designed to hold the used pen needle until it can be disposed of in a suitable sharps container. The actual pen needle is identical between Unifine Pentips and Unifine Pentips Plus in both the physical appearance and functionality.