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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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Seraclone Control AB0+Rh - 07611969950874

Reagent for the negative control in ABO and RH typing with Seraclone ABO and Rh reagent for tube test; 10 ml
Bio-Rad Medical Diagnostics GmbH
805171100
In Commercial Distribution

  • 07611969950874 ()
805171100

  • Antisera matrix (non-reactive) IVD, control

IH-Incubator L - 07611969226344

No Description
Bio-Rad Medical Diagnostics GmbH
009303
In Commercial Distribution

  • 07611969226344 ()


  • Test tube heater

IH-Centrifuge L - 07611969226320

IH-Centrifuge L for centrifugation of IH-System gel cards and/or test tubes.
Bio-Rad Medical Diagnostics GmbH
009301
In Commercial Distribution

  • 07611969226320 ()


  • General-purpose centrifuge IVD

Rejuvesol™ - 00887868260285

No Description
Citra Labs, LLC
PN-7212
In Commercial Distribution

  • 00887868260285 ()
  • 70887868260284 ()
PN-7212

  • Blood transfer set

Ranger™ - 30608223900261

3M™ Ranger® Hose Cap 90026
3M COMPANY
90026
In Commercial Distribution

  • 30608223900261 ()
  • 00608223900260 ()
90026

  • Conduction blood/fluid warmer set

Bair Hugger™ - 30608223241104

3M™ Ranger® Fluid Warming Set, Standard Flow, 10 Per Case 24110
3M COMPANY
24110
Not in Commercial Distribution

  • 30608223241104 ()
  • 00608223241103 ()
24110

  • Conduction blood/fluid warmer set

Aurora Xi - 00810020442199

Aurora Xi Plasmapheresis System with Software Version 2.0
Fresenius Kabi AG
Software Version 2.0
In Commercial Distribution

  • 00810020442199 ()


  • Apheresis system

Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual - 00810020441642

For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the Amicus Separator.
Fresenius Kabi AG
4R2361
In Commercial Distribution

  • 10810020441649 ()
  • 00810020441642 ()
4R2361

  • Apheresis system tubing set

Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual - 00810020441635

For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the Amicus Separator.
Fresenius Kabi AG
4R2360
In Commercial Distribution

  • 10810020441632 ()
  • 00810020441635 ()
4R2360

  • Apheresis system tubing set

AMICUS Separator Legacy Software - 00810020441208

Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.51.0
In Commercial Distribution

  • 00810020441208 ()


  • Apheresis system
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