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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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Medline - 10193489021400

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

  • 20193489021407 ()
  • 10193489021400 ()
HCSFFNVAM

  • Pulmonary resuscitator, manual, single-use

NA - 00643169983892

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 - 00382902606611

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) - 10382902212789

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® - 10381780171898

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

MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10X2) - 03607360047675

No Description
SEBIA
4767
In Commercial Distribution

  • 03607360047675 ()
4767

  • Glycated haemoglobin (HbA1c) IVD, control

HYDRAGEL 30 LDL/HDL CHOL DIRECT - 03607360041390

No Description
SEBIA
4139
In Commercial Distribution

  • 03607360041390 ()
4139

  • Protein electrophoresis IVD, kit, electrophoresis

HYDRAGEL LIPO + Lp(a) K20 - 03607360030073

Lipoprotein + Lp(a) using K20
SEBIA
3007
In Commercial Distribution

  • 03607360030073 ()
3007

  • Protein electrophoresis IVD, kit, electrophoresis

Sample Diluent CAPI 3 IT (10) - 03607360026021

No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent

CAPI 3 URINE - 03607360025130

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 PROTEINE 6 MAXI KIT - 03607360022238

MINICAP PROTEIN MAXI KIT
SEBIA
2223
In Commercial Distribution

  • 03607360022238 ()
2223

  • Protein electrophoresis IVD, kit, electrophoresis

MINICAP CDT - 03607360022085

CARBOHYDRATE DEF TRANSFERRIN BY MINICAP CE
SEBIA
2208
In Commercial Distribution

  • 03607360022085 ()
2208

  • Transferrin/transferrin isoform IVD, kit, electrophoresis

MINICAP PROTEINE 6 - 03607360022030

PROTEIN SEPERATION BY MINICAP
SEBIA
2203
In Commercial Distribution

  • 03607360022030 ()
2203

  • Protein electrophoresis IVD, kit, electrophoresis

CAPILLARYS/MINICAP WASH SOLUTION (2) - 03607360020524

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

CAPILLARYS CDT MAXI KIT - 03607360020296

CARBOHYDRATE DEF TRANSFERRIN BY CE MAXI KIT
SEBIA
2029
In Commercial Distribution

  • 03607360020296 ()
2029

  • Transferrin/transferrin isoform IVD, kit, electrophoresis

CAPILLARYS CDT - 03607360020098

CARBOHYDRATE DEF TRANSFERRING BY CE
SEBIA
2009
In Commercial Distribution

  • 03607360020098 ()
2009

  • Transferrin/transferrin isoform IVD, kit, electrophoresis

CAPILLARYS PROTEINE 6 - 03607360020036

PROTEIN SEPARATION USING CAPILLARY ELECTROPHORESIS
SEBIA
2003
In Commercial Distribution

  • 03607360020036 ()
2003

  • Protein electrophoresis IVD, kit, electrophoresis

POWERWAND™ XL - 10859821006541

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

POWERWAND™ XL - 10859821006534

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

POWERWAND - 10859821006527

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

POWERWAND™ XL-REC - 10859821006510

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

CVC WAND XL - 10859821006503

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 - 10859821006497

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 - 10859821006480

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 - 10859821006473

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

CVC WAND - 10859821006466

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

POWERWAND - 10859821006459

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 - 10859821006442

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 - 10859821006435

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 - 10859821006428

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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