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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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MASK, NIV, FULL FACE, NONVENT, AAV, MED
MEDLINE INDUSTRIES, INC.
HCSFFNVAM
In Commercial Distribution

  • 20193489021407 ()
  • 10193489021400 ()
HCSFFNVAM

  • Pulmonary resuscitator, manual, single-use
CONSOLE 106A3 GEN V ROHS PLX MKS
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00643169983892 ()


  • Cardiac cryosurgical system
BD BBL™ Sensi-Disc™ 6-Place Self-Tamping Dispenser
BECTON, DICKINSON AND COMPANY
260661
In Commercial Distribution

  • 00382902606611 ()
260661

  • Antimicrobial sensitivity disc dispenser IVD
BD BBL™ Sabouraud Dextrose Agar (Deep Fill), Carton of 100 plates
BECTON, DICKINSON AND COMPANY
221278
In Commercial Distribution

  • 30382902212783 ()
  • 10382902212789 ()
  • 00382902212782 ()

  • Outer Diameter: 100 Millimeter
221278

  • Differential/selective agar culture medium IVD
Integra® Miltex® CryoSolutions® Complete Set, 1mm Standard Tip(33511), 1 Cartridge(33518)(23.5g N2O) and 1 Metal Pin(33520)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
33510
In Commercial Distribution

  • H834335101 ()
  • 10381780171898 ()
33510

  • General cryosurgical system, cryogen gas, mechanical
No Description
SEBIA
4767
In Commercial Distribution

  • 03607360047675 ()
4767

  • Glycated haemoglobin (HbA1c) IVD, control
No Description
SEBIA
4139
In Commercial Distribution

  • 03607360041390 ()
4139

  • Protein electrophoresis IVD, kit, electrophoresis
Lipoprotein + Lp(a) using K20
SEBIA
3007
In Commercial Distribution

  • 03607360030073 ()
3007

  • Protein electrophoresis IVD, kit, electrophoresis
No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent
CAPILLARYS 3 URINE KIT IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K192095
SEBIA
2513
In Commercial Distribution

  • 03607360025130 ()
2513

  • Protein electrophoresis IVD, kit, electrophoresis
MINICAP PROTEIN MAXI KIT
SEBIA
2223
In Commercial Distribution

  • 03607360022238 ()
2223

  • Protein electrophoresis IVD, kit, electrophoresis
CARBOHYDRATE DEF TRANSFERRIN BY MINICAP CE
SEBIA
2208
In Commercial Distribution

  • 03607360022085 ()
2208

  • Transferrin/transferrin isoform IVD, kit, electrophoresis
PROTEIN SEPERATION BY MINICAP
SEBIA
2203
In Commercial Distribution

  • 03607360022030 ()
2203

  • Protein electrophoresis IVD, kit, electrophoresis
CAPILLARYS /MINICAP WASH SOLUTION IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K082085.
SEBIA
2052
In Commercial Distribution

  • 03607360020524 ()
2052

  • Wash/cleaning solution IVD, automated/semi-automated system
CARBOHYDRATE DEF TRANSFERRIN BY CE MAXI KIT
SEBIA
2029
In Commercial Distribution

  • 03607360020296 ()
2029

  • Transferrin/transferrin isoform IVD, kit, electrophoresis
CARBOHYDRATE DEF TRANSFERRING BY CE
SEBIA
2009
In Commercial Distribution

  • 03607360020098 ()
2009

  • Transferrin/transferrin isoform IVD, kit, electrophoresis
PROTEIN SEPARATION USING CAPILLARY ELECTROPHORESIS
SEBIA
2003
In Commercial Distribution

  • 03607360020036 ()
2003

  • Protein electrophoresis IVD, kit, electrophoresis
POWERWAND™ XL Quick Kit 5Fr X 10cm Bifurcated
ICU MEDICAL, INC.
Quick Kit 5Fr X 10cm Bifurcated
In Commercial Distribution

  • 20859821006548 ()
  • 10859821006541 ()

  • Catheter Gauge: 5 French
  • Length: 10 Centimeter
94131

  • Peripheral vascular catheter
The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque
ICU MEDICAL, INC.
5Fr X 10cm Bifurcated
In Commercial Distribution

  • 30859821006538 ()
  • 20859821006531 ()
  • 10859821006534 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 5 French
94119

  • Peripheral vascular catheter
The POWERWAND-ED. Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. *Fast-flash. *ZERO-EDGE Transitions. *Power Injectable
ICU MEDICAL, INC.
(ED) 3 Fr X 6 cm
In Commercial Distribution

  • 30859821006521 ()
  • 20859821006524 ()
  • 10859821006527 ()

  • Length: 6 Centimeter
  • Catheter Gauge: 3 French
92019

  • Peripheral vascular catheter
The POWERWAND XL-REC Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque
ICU MEDICAL, INC.
4Fr x 6cm
In Commercial Distribution

  • 30859821006514 ()
  • 20859821006517 ()
  • 10859821006510 ()

  • Catheter Gauge: 4 French
  • Length: 6 Centimeter
95001

  • Peripheral vascular catheter
The CVC WAND XL Max Barrier Kit
ACCESS SCIENTIFIC, LLC
Max Barrier Kit
In Commercial Distribution

  • 20859821006500 ()
  • 10859821006503 ()

  • Length: 6 Centimeter
  • Catheter Gauge: 7 French
93103

  • Peripheral vascular catheter
POWERWAND Quick Kit 3Fr X 6cm
ACCESS SCIENTIFIC, LLC
Quick Kit 3Fr X 6cm
In Commercial Distribution

  • 20859821006494 ()
  • 10859821006497 ()

  • Catheter Gauge: 3 French
  • Length: 6 Centimeter
76416

  • Peripheral vascular catheter
POWERWAND XL Pediatric Kit 3Fr X 6cm
ACCESS SCIENTIFIC, LLC
Pediatric Kit 3Fr X 6cm
In Commercial Distribution

  • 20859821006487 ()
  • 10859821006480 ()

  • Catheter Gauge: 3 French
  • Length: 6 Centimeter
94124

  • Peripheral vascular catheter
POWERWAND XL Quick Kit 3Fr X 6cm
ICU MEDICAL, INC.
Quick Kit 3Fr X 6cm
In Commercial Distribution

  • 20859821006470 ()
  • 10859821006473 ()

  • Length: 6 Centimeter
  • Catheter Gauge: 3 French
94123

  • Peripheral vascular catheter
The CVC WAND Max Barrier Kit
ACCESS SCIENTIFIC, LLC
Max Barrier Kit
In Commercial Distribution

  • 20859821006463 ()
  • 10859821006466 ()

  • Catheter Gauge: 7 French
  • Length: 6 Centimeter
93002

  • Peripheral vascular catheter
Deluxe Dressing Change Kit W/Zpad
ACCESS SCIENTIFIC, LLC
Deluxe Dressing Change kit w/ Zpad
In Commercial Distribution

  • 20859821006456 ()
  • 10859821006459 ()
71751

  • Wearable percutaneous catheter/tube holder
POWERWAND Pediatric Kit 3Fr X 6cm
ACCESS SCIENTIFIC, LLC
Pediatric Kit 3Fr X 6cm
In Commercial Distribution

  • 20859821006449 ()
  • 10859821006442 ()

  • Catheter Gauge: 3 French
  • Length: 6 Centimeter
72626

  • Peripheral vascular catheter
POWERWAND™ XL Basic Kit 4Fr X 10cm
ACCESS SCIENTIFIC, LLC
Basic Kit 4Fr X 10cm
In Commercial Distribution

  • 20859821006432 ()
  • 10859821006435 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 4 French
80801

  • Peripheral vascular catheter
POWERWAND™ XL Basic Kit 4Fr X 8cm
ACCESS SCIENTIFIC, LLC
Basic Kit 4Fr X 8cm
In Commercial Distribution

  • 20859821006425 ()
  • 10859821006428 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 4 French
80800

  • Peripheral vascular catheter
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