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Prometheus ChitoGauze® XR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds

Prometheus ChitoGauze® XR PRO is composed of standard polyester/ravon blend nonwoven medical gauze with a radiopaque filament that is coated with chitosan. The dressing is z-folded to the appropriate size and vacuum sealed in a pre-printed foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-6. The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque filament allows for easy detection via X-ray to prevent the dressing from being inadvertently left on the wound.

The HemCon Bandage OTC is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Bandage OTC also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms. The HemCon Bandage PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins. Hem Con ChitoFlex PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins. The HemCon Patch PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins. The HemCon Strip First Aid PRO is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. The HemCon Strip First Aid PRO also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms. The HemCon Strip PRO is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose-bleeds, surgical debridement sites, skin surface puncture sites and sites involving percutaneous catheters, tubes and pins.

The HemCon® Bandage family of products are lyophilized (freeze dried) chitosan based dressings designed to optimize the muco adhesive surface density and structural integrity of chitosan at the site of injury. The bandages are soft, pliable, off-white, non-woven, lamellar dressings composed of a non-mammalian biocompatible, hydrophilic cellulose polymer, poly-N-acetylglucosamine (NAG), isolated from arctic shrimp "Pandalus Borealis' chitosan. When applied directly to a wound the dressing controls bleeding. The chitosan dressings offer an antibacterial barrier against a wide range of gram positive and gram negative organisms including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied. The HemCon Bandage Family of products may be manufactured to any size and are currently available in sizes: 1.5" x 1.5", 1" x 4", 2" x 2", 2"x 4", 4"x 4",3" x 9″ and 3" x 28". The HemCon Bandage family products are safe, durable, highly effective, and do not contain human proteins or clotting factors.

HemCon GuardaCare™XR is a hemostatic dressing intended for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.

The GuardaCare™XR dressing is composed of a radiopaque element attached to standard polyester/ravon blend non-woven medical gauze that is coated with chitosan. The product is produced in multiple sizes; e.q. two (2) inches by two (2) inches, eightply: four (4) inches by four (4) inches, eight-ply; and four (4) inches by two (2) yards (zfolded 4"x4"). All sizes are a single continuous length that is z-folded to the appropriate size. The products are double-pouched. The inner pouch is peelable foil and the outer pouch is clear peelable polvethylene terephthalate (PET). The pouched dressings are terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10 °. The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque element allows for easy detection via x-ray to prevent the dressing from being inadvertently left in a surgical cavity.

The ChitoGauze™ FUSION™ Wound Packing Kit is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

ChitoGauzeXR is composed of polyester/rayon blend non-woven medical gauze coated with chitosan and with a radiopaque filament attached. The legally marketed ChitoGauzeXR dressing has been modified to co-package the ChitoGauzeXR hemostatic dressing with uncoated polyester/rayon blend non-woven medical gauze (also referred to as "uncoated gauze") to create the ChitoGauze FUSION Wound Packing Kit. ChitoGauze FUSION may be produced in multiple sizes within the scope of the currently validated sizes of the ChitoGauze family of dressings. Both the ChitoGauzeXR and the uncoated gauze are Z-folded to the appropriate size and contain a radiopaque element. To visually distinguish between the two, the ChitoGauzeXR dressing contains one radiopaque yarn and the uncoated gauze contains two radiopaque yarns. The dressings are co-packaged in a pouching configuration consisting of an inner dispenser pouch and outer pouch. The inner nylon/LDPE pouch will hold both gauze components and is intended to allow controlled dispensing of the gauze dressings through a hole on top. Because there is a hole on tope, this pouch is not intended to act as a sterile barrier. The outer foil pouch is intended to provide a barrier to protect the product and maintain product sterility. The ChitoGauze FUSION Wound Packing Kit is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10 to the power of -6. The hemostatic properties of chitosan enhance the ability of the ChitoGauzeXR to control bleeding. The uncoated gauze is intended to be used as a backing or securement dressing and to absorb excess fluid. The co-packaging of the two gauze types provides an added level of convenience to the user and facilitates ease-of-use. The radiopaque filament allows for easy detection via x-ray to prevent the dressing from being inadvertently left on the wound.

ChitoGauze™XR is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

The ChitoGauze dressing is composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan. This submission for ChitoGauze™XR adds a radiopaque filament to models of various dimensions of the legally marketed dressing. The ChitoGauze™XR dressings are z-folded to the appropriate size and packaged in a single heat-sealed foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10 - The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque filament allows for easy detection via x-ray to prevent the dressing from being inadvertently left on the wound.

ChitoGauze™ is a hemostatic dressing for the external, temporary control of severely bleeding wounds. ChitoGauze™ is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.

The ChitoGauze dressing is composed of standard polyesterfrayon blend non-woven medical gauze that is coated with chitosan. This submission adds models of various dimensions to the legally marketed four inch by four yard (4" x 4 yds) dressing. ChitoGauze dressings are z-folded and packaged in a peelable foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10th. The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding.

ChitoGauze™ is intended to be a hemostatic wound dressing. Indications for Use (Rx): ChitoGauze is a hemostatic dressing for the external, temporary control of severely bleeding wounds. Indications for Use (OTC): ChitoGauze is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.

The ChitoGauze dressing is composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan. The four inch by four yard (4" x 4 yds) dressing is z-folded and packaged in a peelable foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-6. The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding.

HemCon® Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon® Bandage also controls bleeding in patients following hemodialysis. The HemCon® Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding.

The HemCon® Bandage is manufactured from chitosan. When applied directly to the wound, the HemCon® Bandage controls bleeding. The HemCon® Bandage is a sterile chitosan based dressing intended for use for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HernCon® Bandage also controls bleeding in patients following hemodialysis. The HemCon® Bandage OTC is indicated for the local management of bleeding such as laceration and minor bleeding. The original HemCon® Bandage and HemCon® Bandage OTC were cleared via 510(k) K043050 on 03 June 2005 to include the description that the bandage provides an antibacterial barrier as demonstrated by AATCC Test Method 100-2004, Evaluation of Antibacterial Finishes (Technical Manual of the America Association of Textile Chemists and Colorists) in laboratory testing for two microorganisms. This submission expands this antibacterial claim to a total of twenty-four micro-organisms. The HemCon® Bandage is similar to the original HemCon® Bandage and another antibacterial wound dressing, Maersk Medical's Arglaes-AB Antimicrobial (K990810, cleared 17 September 1999), the HemCon® Bandage was challenged with microbial strains in vitro to support the claim of antibacterial barrier activity and extend the list of microorganisms used in the challenge test.

The HemCon Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon Bandage also controls bleeding in patients following hemodialysis. The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. HemCon ChitoFlex™ Surgical is intended for use as a dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries. The dressing is also indicated for the control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

The HemCon dressings are a hemostatic chitosan dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the dressing also controls bleeding in patients following hemodialysis.