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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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POWERWAND™ XL Max Barrier Kit 4Fr X 8cm
ICU MEDICAL, INC.
Max Barrier Kit 4Fr X 8cm
In Commercial Distribution

  • 20859821006173 ()
  • 10859821006176 ()

  • Length: 8 Centimeter
  • Catheter Gauge: 4 French
94106

  • Peripheral vascular catheter
Quick Kit 4Fr X 8cm
ICU MEDICAL, INC.
Quick Kit 4Fr X 8cm
In Commercial Distribution

  • 20859821006166 ()
  • 10859821006169 ()

  • Length: 8 Centimeter
  • Catheter Gauge: 4 French
94104

  • Peripheral vascular catheter
The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
ACCESS SCIENTIFIC, LLC
6Fr
In Commercial Distribution

  • 30859821006156 ()
  • 20859821006159 ()
  • 10859821006152 ()

  • Length: 7 Centimeter
  • Catheter Gauge: 6 French
91012

  • Vascular catheter introduction set, nonimplantable
The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
ACCESS SCIENTIFIC, LLC
5Fr
In Commercial Distribution

  • 30859821006149 ()
  • 20859821006142 ()
  • 10859821006145 ()

  • Length: 7.25 Centimeter
  • Catheter Gauge: 5 French
91008

  • Vascular catheter introduction set, nonimplantable
The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
ACCESS SCIENTIFIC, LLC
4Fr
In Commercial Distribution

  • 30859821006132 ()
  • 20859821006135 ()
  • 10859821006138 ()

  • Length: 7.25 Centimeter
  • Catheter Gauge: 4 French
91010

  • Vascular catheter introduction set, nonimplantable
The CVC WAND Safety Introducer with Valved Peelabel Sheath
ACCESS SCIENTIFIC, LLC
7Fr
In Commercial Distribution

  • 30859821006125 ()
  • 20859821006128 ()
  • 10859821006121 ()

  • Length: 6 Centimeter
  • Catheter Gauge: 7 French
93102

  • Vascular catheter introduction set, nonimplantable
The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque
ICU MEDICAL, INC.
3Fr x 6cm
In Commercial Distribution

  • 30859821006101 ()
  • 20859821006104 ()
  • 10859821006107 ()

  • Length: 6 Centimeter
  • Catheter Gauge: 3 French
94122

  • Peripheral vascular catheter
The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. *Fast-flash. *ZERO-EDGE Transitions. *Power Injectable
ICU MEDICAL, INC.
5Fr X 10cm
In Commercial Distribution

  • 30859821006088 ()
  • 20859821006081 ()
  • 10859821006084 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 5 French
92006

  • Peripheral vascular catheter
The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. *Fast-flash. *ZERO-EDGE Transitions. *Power Injectable
ICU MEDICAL, INC.
4Fr X 8cm
In Commercial Distribution

  • 30859821006057 ()
  • 20859821006050 ()
  • 10859821006053 ()

  • Length: 8 Centimeter
  • Catheter Gauge: 4 French
92005

  • Peripheral vascular catheter
The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque
ICU MEDICAL, INC.
4Fr x 10cm
In Commercial Distribution

  • 30859821006026 ()
  • 20859821006029 ()
  • 10859821006022 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 4 French
94103

  • Peripheral vascular catheter
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
BD BBL™ Sensi-Disc™ 6-Place Self-Tamping Dispenser
BECTON, DICKINSON AND COMPANY
260661
In Commercial Distribution

  • 00382902606611 ()
260661

  • Antimicrobial sensitivity disc dispenser IVD
STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.
Xvivo Perfusion AB
19004
In Commercial Distribution

  • 07350069520036 ()

  • Total Volume: 500 Milliliter
19004

  • Donor-organ/tissue/cell preservation solution
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
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
Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies.
GAMBRO DASCO SPA
6023006700
Not in Commercial Distribution

  • 07332414042035 ()
103453

  • Haemodialysis system dialysate delivery unit
The POWERWAND™ XL Introducer with Extended Dwell Catheter, 4Fr x 10cm
ACCESS SCIENTIFIC, LLC
Alternate Site Kit 4Fr x 10cm
In Commercial Distribution

  • 00859821006681 ()

  • Pressure: 325 Pound per Square Inch
  • Needle Gauge: 21 Gauge
  • Length: 10 Centimeter
  • Catheter Gauge: 4 French
80701

  • Peripheral vascular catheter
BLOOD CULTURE, LUER LOCK ACCESS DEVICE
MEDLINE INDUSTRIES, INC.
BCLLAD
In Commercial Distribution

  • 30193489189654 ()
  • 10193489189650 ()
  • 20193489189657 ()
BCLLAD

  • Blood collection set, invasive
BD MAX UVE Specimen Collection Kit
BECTON, DICKINSON AND COMPANY
443376
Not in Commercial Distribution

  • 30382904433766 ()
  • 00382904433765 ()
443376

  • Urogenital specimen collection kit IVD, clinical
  • Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
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