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The Medline General Surgery Tray contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing procedures and surgeries. The intended products assembled in these kits will not be changed from the manufacturer's original intended use.

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The Medline Cardiovascular Procedure Kit contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing cardiovascular procedures and surgeries. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.

The Medline Cardiovascular Procedure Kit is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits are assembled for customer convenience using Medline and other manufacturer's currently manufactured/marketed components. Customers specify the kit contents, quantity, and placement of individual components in the kit. A component listing is provided within this submission, which includes the name and regulatory status of components that can be selected for placement in various configurations of the final Medline Cardiovascular Kits. The BOM provides the corresponding FDA product codes, and reference to respective marketing clearances (as applicable). These included components are standard for cardiovascular procedures. The intended use of the products assembled in the final Medline Cardiovascular Procedure Kit will not be changed. These components are all legally marketed drug products, and/or medical devices that are either: (1) pre-amendment devices; (2) 510(k)-cleared devices; or (3) 510(k) exempt devices. Commodity products, not regulated by FDA, are additionally included in the proposed kit. The customer may also specify a certain brand of similar items or minor variations of items. If additional components and/or manufacturers must be added to this list, we certify the regulatory compliance of the added components and maintain the information in our internal Device Master Record.

The D.I.R.R.A. surgical drape device kit is composed of natural or synthetic materials and intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination.

The DIRRA surgical drape device kit is composed of natural or synthetic materials and intended to be used as protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination. The DIRRA surgical drape device kit is to be used by medical and dental professionals when performing surgical procedures. The DIRRA surqical drape device kit consists of the following components: Gown w/ paper towel (2), Mayo stand cover (1), Sterile sheet (1), Patient drape (1), Transparent drape (1), Adhesive strip (4), Tube holder (1), Cord drape (2), Suction tubing w/tip (1), Flat gauze (20), Round gauze sponge (5), Plastic tray (1), Transparent adhesive film (3), Connector for suction tubing (1), Kit wrapping drape (1). All the components are wrapped in the DIRRA surgical drape device kit wrapping drape which is closed with a label. The final measurement of the kit (not enveloped) is approximately cm.30x30x10. The kit is then enveloped in sequence and in accordance with the instructions for use. The pack is then inserted in the Sterilization plastic/tyvek pouch and the pouch is sealed. 2 Kits are put into one cardboard box along with instructions for use,. The box is then closed and sterilized by Bioster. A sterilization batch number is applied on the box after the sterilization process has been completed.

The Quick-Tap® Paracentesis Kit, Tray and Needle are indicated to relieve pressure by draining fluid from the peritoneal space. The fluid may be undergo diagnostic testing to assess for chemistries, infection or abnormal cells.

Abdominal paracentesis is a procedure used to remove bodily fluid from the peritoneal cavity. Fluid can be the result of liver disease, congestive heart failure or other disease that result in "ascites" fluid. Fluid may also be in the form of blood from perforated organs due to trauma. The fluid is susceptible to infection. Abdominal paracentesis provides therapeutic relief to patients who experience bloating and difficult breathing. The procedure serves a diagnostic purpose, as well. Typically, fluid specimens are sent to a laboratory for microbiological, chemical and histological analysis. Abdominal paracentesis can be performed at bedside or in a treatment center. The patient is prepped using sterile technique and local anesthetic. The sitting position is preferred so that gravity can assist. If preferred, a skin nick is performed with a scalpel and a large bore outer cannula is introduced into the peritoneal cavity midline between the umbilicus and pubis. A syringe can be used to collect the first sample of fluid from the patient confirming a suitable puncture site. The inner needle is withdrawn and disposed of leaving the outer cannula in place. Specimen tubes stand ready for specimen collection. The large majority of fluid is drained into bags or large containers and disposed of. There are no guidelines or standard of care that define the amount or rate of ascites fluid evacuation other than to monitor for signs of hypovolemic shock. One to two liters can be evacuated at one session. After paracentesis the cannula is removed and an adhesive bandage is placed over the puncture site. The patient is then monitored briefly for signs of distress such as persistent bleeding from the puncture site, faintness, anxiety, abnormal pulse, temperature etc. Complications are rare but can include hemorrhage, perforation of abdominal organs, wound infection and hypovolemic shock. There are a variety of disposable instruments used for paracentesis. These include generic angio-introducer catheters and specific needle/cannula combinations for paracentesis. Figure A-I illustrates the Ballard, Caldwell® Paracentesis Needle/Cannula. Our proposed paracentesis needles (and thus trays and kits) are substantially equivalent in design, composition, technology and function to our present paracentesis trays (see predicate devices).

The AMSINO TRACHEOSTOMY CARE TRAY is intended for use in the cleaning and maintenance of Tracheostomy sites.

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THE INTENDED USE OF THE WORLDWIDE MEDICAL MODELOW FOR BONE MARROG OF THE BONE MARROW For PATHOLOGICAL IS TO OBTAIN A SAMPLE BIDPSY TRAY EXAMINATION IN THE DIALNOSIS + TREATIMENT OF VARIOUS DISEASES

Bone Marrow Biopsy Procedure Tray

Opportunity Inc.'s Bone Marrow and Aspiration Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing bone marrow surgical procedures.

Bone Marrow Biopsy and Aspiration Tray

Opportunity Inc.'s General Purpose Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing general surgical procedures.

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Presbyterian Linen Services Surgical Packs are intended to be used in various surgical procedures. The packs provide sterile gowns, drapes and towels to be used during procedures to protect both the surgical patient and the operating room personnel from transfer of microbial and other contamination. Surgical towels provide additional absorption of blood and body fluids when used to square off a surgical site, or may be used by operating room personnel for drying of hands after scrubbing.

Presbyterian Linen Services Surgical Packs are packs composed of reusable gowns, drapes, and toweling, the specifics of which are tailored to the customer's specifications for that procedure.