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The D-Stat Radial Topical Hemostat is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

D-Stat Radial topical hemostat (D-Stat Radial) is a hemostatic band consisting of an application device containing a lyophilized pad consisting of thrombin, sodium carboxylmethylcellulose and calcium chloride in a nonwoven gauze, and an adjustable retention strap and attached foam pads. Hemostasis is achieved by the physiological coagulation-inducing properties of the lyophilized pad combined with the compression delivered by the application device. The D-Stat Radial has been sterilized with irradiation.

The D-Stat Dry Silver and D-Stat Dry Clear Silver are applied topically as an adjunct to manual compression and are indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths. D-Stat Dry Silver and D-Stat Dry Clear Silver contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad. The D-Stat Dry Wrap Silver hemostatic bandage and Thrombix Silver Hemostasis Patch are applied topically as an adjunct to manual compression and are indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes. D-Stat Dry Wrap Silver and Thrombix Silver contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

The D-Stat Dry Silver, D-Stat Dry Clear Silver, D-Stat Dry Wrap Silver and Thrombix Silver products are non-woven gauze pads lyophilized (frecze-dried) with procoagulant (thrombin, calcium chloride and sodium carboxymethylcellulose) and antimicrobial (ionic silver water) components. The D-Stat Drv/Wrap/ Thrombix pad creates a physical barrier to blood flow and facilitates hemostasis by the physiological coagulation-inducing properties of the lyophilized pad combined with compression. The lyophilized components (including thrombin) facilitate hemostasis through enzymatic cleavage and conversion of fibrinogen to fibrin. These products contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad and have not been clinically tested for their ability to reduce local infection, catheter-related bloodstream infections (CRBSI) and skin colonization of microorganisms commonly related to CRBSI . In the presence of fluids (i.e., blood and wound fluids), ionic silver is released from the silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad. Ionic silver, an atom of silver that is missing one electron, provides the antimicrobial property by altering the protein structure and preventing bacterial cells from carrying out normal functions. The D-Stat Silver products demonstrated an antimicrobial effect in AATCC Test Method 100-2004 and Zone of Inhibition laboratory testing. An adhesive foam or clear bandage accompanies some products in the family. All products are sterilized by electron-beam irradiation and are intended for single use only.

The D-Stat Rad-Band is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The D-Stat Rad-Band consists of a gauze pad secured to a release tab and retainer pad on a polycarbonate retainer at the end of an adjustable copolymer retention strap. Two foam pads included on the strap can be adjusted (or removed) for patient comfort. The D-Stat Rad-Band has a lyophilized non-woven gauze pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride to facilitate hemostasis. By pulling the release tab between the gauze pad and the retainer after hemostasis is achieved, the retention strap/retainer can be removed from the patient, leaving the gauze pad behind on the access site. The D-Stat Rad-Band includes an adhesive bandage.

The D-Stat® Dry Wrap hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The D-Stat® Dry Wrap Hemostatic Bandage consists of a lyophilized pad containing bovinederived thrombin as an aid to hemostasis (King Pharmaceuticals license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. The sterile device is sold in a foil pouch and is ready to use. The end user removes the D-Stat Dry Wrap from the pouch and applies the device to the bleeding site. Included is a transparent sterile bandage attached to the primary packaging to apply over the hemostatic pad. The pad has a slit approximately half the length of the pad to allow for the wrapping of the pad around vascular access catheters, like PICC (peripherally inserted central catheter) lines. The D-State Dry Wrap is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical carrier to bleeding.

The D-Stat Dry Clear is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing a 4-6 Fr. introducer sheath.

The D-Stat® Dry Clear Hemostatic Bandage consists of a lyophilized pad containing bovinederived thrombin as an aid to hemostasis (King Pharmaceutical license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. Included is a transparent sterile bandage attached to the primary packaging to apply over the hemostatic pad. The only difference between the D-Stat® Dry Clear Hemostatic Bandage and the predicate is the replacement of the opaque sterile bandage included with the device with a transparent sterile bandage. The D-Stat® Dry Clear is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin. This fundamental scientific technology is exactly the same as the predicate D-Stat Dry hemostatic bandage.

The Thrombix™ Patch is applied topically and is indicated as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The Thrombix " Patch thrombin hemostasis patch consists of a lyophilized patch containing bovine derived thrombin as an aid to hemostasis (King Pharmaceuticals license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. The Thrombix" Patch is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.

The Thrombi-Paste® Thrombin/gelatin powder paste hemostat is applied topically for temporary control of moderate to severely bleeding wounds and for the local management of surface bleeding from vascular access sites and percutaneous tubes and catheters.

Each Thrombi-Paste Thrombin/gelatin powder paste hemostat includes the following components; A 10 mL syringe with attached mixing luer filled with 550mg of powdered absorbable gelatin sponge, USP (manufactured by Vascular Solutions, Inc. (VSI)), A vial of Bovine-derived Thrombin (5,000 IU, supplied to VSI by King Pharmaceuticals, U.S. license # 977), A diluent vial (5 mL, Supplied to VSI by Chesapeake Biological Laboratories, U.S. registration # 1123903), Mixing accessories (10 mL syringe and needleless, non-coring vial access device) and Applicator tips (1 - small bore tip, 1 - large bore tip). The pouch containing the syringe with gelatin powder also contains a desiccant packet to maintain low moisture levels.

The ThrombiGe1® thrombin/gelatin foam hemostat is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds.and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The ThrombiGel® thrombin/gelatin foam hemostat consists of a lyophilized absorbable gelatin sponge, USP containing thrombin, sodium carboxymethylcellulose (CMC), and calcium chloride. The ThrombiGel® thrombin/gelatin foam hemostat is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin. The ThrombiGel® thrombin/gelatin foam hemostat is wetted before use with sterile water for injection or saline (not provided.) There are three versions of the pad which differ in their dimensions. The ThrombiGel® 10 thrombin/gelatin foam hemostat is approximately 10 cm³, the ThrombiGel® 40 thrombin/gelatin foam hemostat is approximately 40 cm² and the ThrombiGel® 100 thrombin/gelatin foam hemostat is approximately 100 cm . A desiccant is added to the package to maintain the moisture content.

The D-Stat Dry is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths.

The D-Stat Dry Hemostatic Bandage consists of the following components: - Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose (CMC) and calcium chloride - Adhesive bandage The D-Stat Dry Hemostatic Bandage achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by the bandage. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.

The ThrombiGel thrombin/gelatin foam hemostat is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percularedus and or tubes.

The ThrombiGel thrombin/gelatin foam hemostat consists of a lyophilized gelatin foam pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride. The ThrombiGel is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.