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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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eSensor® XT-8 - 00857167005245

eSensor® Warfarin Sensitivity Test Amplification Reagents (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005245 ()
MT002001

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

eSensor® XT-8 - 00857167005153

eSensor® Cystic Fibrosis (CF) Genotyping Test (24)
GENMARK DIAGNOSTICS, INC.
eSensor® Cystic Fibrosis (CF)
Not in Commercial Distribution

  • 00857167005153 ()
MT002015

  • Cystic fibrosis IVD, kit, multiplex

eSensor® XT-8 - 00857167005061

eSensor® Warfarin Sensitivity Test Cartridges (WST) (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005061 ()
MT002000

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

Newtowne Hyperbarics - 00865439000201

Class 4 model, 24" diameter, portable hyperbaric chamber.
TYPHOON WATER WARES LTD
Class 4-24
Not in Commercial Distribution

  • 00865439000201 ()

  • Length: 89 Inch
  • Outer Diameter: 24 Inch


  • Hyperbaric chamber, portable

HIgH-Flo™ Needle Set - 00659443000674

24 Gauge Needle Sets - 4 needles - 12 mm
REPRO MED SYSTEMS, INC.
RMS42412
In Commercial Distribution

  • 10659443000671 ()
  • 00659443000674 ()

  • Needle Gauge: 24 Gauge
RMS42412

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000667

24 Gauge Needle Sets - 4 needles - 9 mm
REPRO MED SYSTEMS, INC.
RMS42409
In Commercial Distribution

  • 10659443000664 ()
  • 00659443000667 ()

  • Needle Gauge: 24 Gauge
RMS42409

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000650

24 Gauge Needle Sets - 4 needles - 6 mm
REPRO MED SYSTEMS, INC.
RMS42406
In Commercial Distribution

  • 10659443000657 ()
  • 00659443000650 ()

  • Needle Gauge: 24 Gauge
RMS42406

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000643

24 Gauge Needle Sets - 3 needles - 14 mm
REPRO MED SYSTEMS, INC.
RMS32414
In Commercial Distribution

  • 10659443000640 ()
  • 00659443000643 ()

  • Needle Gauge: 24 Gauge
RMS32414

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000636

24 Gauge Needle Sets - 3 needles - 12 mm
REPRO MED SYSTEMS, INC.
RMS32412
In Commercial Distribution

  • 10659443000633 ()
  • 00659443000636 ()

  • Needle Gauge: 24 Gauge
RMS32412

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000629

24 Gauge Needle Sets - 3 needles - 9 mm
REPRO MED SYSTEMS, INC.
RMS32409
In Commercial Distribution

  • 10659443000626 ()
  • 00659443000629 ()

  • Needle Gauge: 24 Gauge
RMS32409

  • Subcutaneous infusion/injection port needle
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