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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 - 10859821006176

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

POWERWAND™ XL - 10859821006169

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

PICC WAND - 10859821006152

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

PICC WAND - 10859821006145

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

PICC WAND - 10859821006138

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

CVC WAND XL - 10859821006121

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

POWERWAND XL - 10859821006107

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

POWERWAND - 10859821006084

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

POWERWAND - 10859821006053

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

POWERWAND™ XL - 10859821006022

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

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

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

STEEN Solution™ - 07350069520036

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® - 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

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

PHOENIX - 07332414042035

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

POWERWAND™ XL - 00859821006681

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

MEDLINE - 10193489189650

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 - 30382904433766

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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