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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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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

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

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
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