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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-612C
In Commercial Distribution

  • M729800612C2 ()
  • M729800612C0 ()
  • M729800612C1 ()
  • M729800612C3 ()

  • Catheter Gauge: 6 to 12 French


  • Femoral artery closure plug/patch, collagen
SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from rooster combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-5555-01
Not in Commercial Distribution

  • M717715655554 ()
  • M717715655553 ()
  • M717715655552 ()
  • M717715655550 ()
7156-5555

  • Synovial fluid supplementation medium
SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-4444-1
In Commercial Distribution

  • M717715644440 ()
  • M717715644442 ()
  • M717715644443 ()
  • M717715644444 ()
7156-4444

  • Synovial fluid supplementation medium
The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 10Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-1012XL
In Commercial Distribution

  • M7298001012XL2 ()
  • M7298001012XL0 ()
  • M7298001012XL1 ()
  • M7298001012XL3 ()

  • Catheter Gauge: 10 to 12 French


  • Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution

  • M729700580I1 ()
  • M729700580I0 ()
  • M729700580I3 ()

  • Catheter Gauge: 7 French
  • Catheter Gauge: 6 French


  • Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution

  • M729700500DX1 ()
  • M729700500DX0 ()
  • M729700500DX3 ()

  • Catheter Gauge: 5 French


  • Femoral artery closure plug/patch, collagen
The ResQCPR system contains two ResQPODs and one ResQPump
ADVANCED CIRCULATORY SYSTEMS INC
12-0825-000
In Commercial Distribution

  • M5921208220000 ()
  • M5921208250001 ()
  • M5921208230001 ()


  • Cardiac resuscitator, manual
The Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH.
Beyond Air, Inc.
90031
In Commercial Distribution

  • B882900310 ()
  • B882900311 ()
  • B882900312 ()


  • Nitric oxide delivery system, secondary
90017 is a kit containing two off-the-shelf components: - 1: (61928) 22M-22F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 22mm-diameter breathing circuit.
Beyond Air, Inc.
90017
In Commercial Distribution

  • B882900171 ()
  • B882900170 ()
  • B882900172 ()


  • Nitric oxide delivery system, secondary
The Luer elbow is a component to the gas sampling port which fits on a breathing circuit.
Beyond Air, Inc.
90016
In Commercial Distribution

  • B882900161 ()
  • B882900160 ()
  • B882900162 ()


  • Nitric oxide delivery system, secondary
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