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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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COBE® Spectra - 05020583706309

Bone Marrow Processing Set
TERUMO BCT, INC.
70630
In Commercial Distribution

  • 05020583706309 ()
  • 35020583706300 ()


  • Blood transfer set

COBE® Spectra - 05020583706293

White Blood Cell-Functionally Closed Tubing
TERUMO BCT, INC.
70629
Not in Commercial Distribution

  • 05020583706293 ()
  • 35020583706294 ()


  • Blood transfer set

COBE® Spectra - 05020583706101

Auto PBSC Set
TERUMO BCT, INC.
70610
In Commercial Distribution

  • 05020583706101 ()
  • 35020583706102 ()


  • Blood transfer set

COBE® Spectra - 05020583705005

Therapeutic Plasma Exchange Set
TERUMO BCT, INC.
70500
In Commercial Distribution

  • 05020583705005 ()
  • 35020583705006 ()
70500

  • Blood transfer set

TransCyte - 00618474000046

TRANSCYTE® is a human fibroblast-derived temporary skin substitute consisting of a polymer membrane and donated neonatal human fibroblast cells cultured under aseptic conditions in vitro on a nylon mesh. Prior to cell growth, this nylon mesh is coated with porcine dermal collagen and bonded to a polymer membrane (silicone). This membrane provides a transparent synthetic epidermis when applied. As fibroblasts proliferate within the nylon mesh, they secrete human dermal collagen, matrix proteins and growth factors. Following freezing, no cellular metabolic activity remains; however, the tissue matrix and bound growth factors are left intact. The human fibroblast-derived temporary skin substitute provides a temporary protective barrier. TRANSCYTE is transparent and allows direct visual monitoring of the wound bed.
ORGANOGENESIS INC.
10633
In Commercial Distribution

  • 00618474000046 ()


  • Skin regeneration template, human-/animal-derived

GS - 00847865013253

GS HIV Combo Ag/Ab EIA, Conjugate 2 Diluent, 40 mL
Bio-RAD Laboratories, Inc.
26228
In Commercial Distribution

  • 00847865013253 ()

  • Total Volume: 40 Milliliter
26228

  • HIV1/HIV2 antigen/antibody IVD, reagent

GS - 00847865013239

GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 18 mL
Bio-RAD Laboratories, Inc.
26226
In Commercial Distribution

  • 00847865013239 ()

  • Total Volume: 18 Milliliter
26226

  • HIV1/HIV2 antigen/antibody IVD, reagent

GS - 00847865013215

GS HIV Combo Ag/Ab EIA, Cutoff Calibrator, 1.7 mL
Bio-RAD Laboratories, Inc.
26224
In Commercial Distribution

  • 00847865013215 ()

  • Total Volume: 1.7 Milliliter
26224

  • HIV1/HIV2 antigen/antibody IVD, calibrator

GS - 00847865013192

GS HIV Combo Ag/Ab EIA, HIV-1 Ab Pos Ctrl, 1.5 mL
Bio-RAD Laboratories, Inc.
26221
In Commercial Distribution

  • 00847865013192 ()

  • Total Volume: 1.5 Milliliter
26221

  • HIV1/HIV2 antigen/antibody IVD, control

Puriblood - 04719878520515

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-08-PS
In Commercial Distribution

  • 14719878520512 ()
  • 04719878520515 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520508

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-07-PS
In Commercial Distribution

  • 14719878520505 ()
  • 04719878520508 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520492

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-06-PS
In Commercial Distribution

  • 14719878520499 ()
  • 04719878520492 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520485

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-05-PS
In Commercial Distribution

  • 14719878520482 ()
  • 04719878520485 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520478

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-04-PS
In Commercial Distribution

  • 14719878520475 ()
  • 04719878520478 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520461

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-01-PS
In Commercial Distribution

  • 14719878520468 ()
  • 04719878520461 ()


  • Blood transfusion set, non-exchange

Puriblood - 04719878520003

No Description
PURIBLOOD MEDICAL CO., LTD.
LRW-50-12-PS
In Commercial Distribution

  • 04719878520003 ()
  • 14719878520000 ()


  • Blood transfusion set, non-exchange

Virtue CPKit - 04719875912177

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15Q
In Commercial Distribution

  • 04719875912177 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912160

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15S
In Commercial Distribution

  • 04719875912160 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912153

No Description
AEON BIOTHERAPEUTICS CORP.
APA-10G
In Commercial Distribution

  • 04719875912153 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912146

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15G
In Commercial Distribution

  • 04719875912146 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912139

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15D
In Commercial Distribution

  • 04719875912139 ()


  • Haematological concentrate system preparation kit, platelet concentration

Virtue CPKit - 04719875912122

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15
In Commercial Distribution

  • 04719875912122 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912054

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15D
In Commercial Distribution

  • 04719875912054 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912047

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15Q
In Commercial Distribution

  • 04719875912047 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912030

No Description
AEON BIOTHERAPEUTICS CORP.
ABA-15S
In Commercial Distribution

  • 04719875912030 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912023

No Description
AEON BIOTHERAPEUTICS CORP.
APA-10G
In Commercial Distribution

  • 04719875912023 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912016

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15G
In Commercial Distribution

  • 04719875912016 ()


  • Haematological concentrate system preparation kit, platelet concentration

Aeon CPKit - 04719875912009

No Description
AEON BIOTHERAPEUTICS CORP.
APA-15
In Commercial Distribution

  • 04719875912009 ()


  • Haematological concentrate system preparation kit, platelet concentration

DiaSpect Tm Cuvettes - 14048534001967

For the quantitative determination of hemoglobin in whole blood.
EKF-diagnostic GmbH
7049-3013-0369
In Commercial Distribution

  • 24048534001964 ()
  • 14048534001967 ()
  • 04048534001953 ()
900-500

  • Haemoglobin analyser IVD, point-of-care

Fenwal Product Sample Pack - 14086000101421

For Sampling of Collected Blood and Blood Components. For Laboratory Testing Only. Sterile Fluid Path.
Fresenius Kabi AG
4R2335H
In Commercial Distribution

  • 14086000101421 ()
  • 04086000101424 ()
  • 24086000101428 ()
4R2335H

  • Blood transfer set
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