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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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300 mL Empty Bag for Pooling of Blood Components.
MACO PHARMA
VSE
In Commercial Distribution

  • 13567050052747 ()
  • 03567050052740 ()
VSE3010XD

  • Blood donor set, single-pack
Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b product consists of a transfer line, drip chamber, leukoreduction filter, by-pass tubing and transfer bag. It is sterilized by electron beam (beta irradiation) and is supplied with sterile and non-pyrogenic fluid pathways.
MACO PHARMA
KSV
In Commercial Distribution

  • 13567050035344 ()
  • 03567050035347 ()
KSV0004XD

  • Blood donor set, single-pack
No Description
Luvo Medical Technologies Inc
WORLDPRP
In Commercial Distribution

  • 00754016214127 ()
  • 10754016214124 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
Biosafe S.A.
CryoSC-Db Seal positioner
In Commercial Distribution

  • 07640125650570 ()
7035

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
CryoSC-D Seal positioner
Not in Commercial Distribution

  • 07640125650563 ()
7026

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
Insertion Tool
Not in Commercial Distribution

  • 07640125650556 ()
  • 07640125650648 ()
7030

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
Metal Storage Canister
In Commercial Distribution

  • 07640125650549 ()
  • 07640125650532 ()
  • 07640125650631 ()
7012

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
Overwrap Bag
In Commercial Distribution

  • 07640125650518 ()
  • 07640125650525 ()
4085

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
Traceability Labels for Bioarchive
Not in Commercial Distribution

  • 07640125650501 ()
7031

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
Traceability Labels for cryopreservation
Not in Commercial Distribution

  • 07640125650495 ()
7011

  • Blood centrifugation system containment kit
No Description
Biosafe S.A.
FB-100.2b
Not in Commercial Distribution

  • 07640125650419 ()
  • 07640125650402 ()
10041

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
FB-100.2
Not in Commercial Distribution

  • 7640125650396 ()
  • 07640125650389 ()
10032

  • Blood/tissue storage/culture container
No Description
Biosafe S.A.
FB-100.1
Not in Commercial Distribution

  • 07640125650372 ()
  • 07640125650365 ()
10023

  • Blood/tissue storage/culture container
No Description
Roche Diagnostics GmbH
04784600162
In Commercial Distribution

  • 07613336183151 ()
04784600162

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
No Description
Roche Diagnostics GmbH
09118551162
In Commercial Distribution

  • 07613336228449 ()
  • 07613336183069 ()
09118551162

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, kit, chemiluminescent immunoassay
Syphilis PC Elecsys
Roche Diagnostics GmbH
06923364162
In Commercial Distribution

  • 07613336183175 ()
06923364162

  • Treponema pallidum total antibody IVD, control
No Description
Roche Diagnostics GmbH
09015051162
In Commercial Distribution

  • 07613336228463 ()
  • 07613336183083 ()
09015051162

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay
PreciControl Release Syphilis
Roche Diagnostics GmbH
09366903190
In Commercial Distribution

  • 07613336183007 ()
09366903190

  • Treponema pallidum total antibody IVD, control
No Description
Roche Diagnostics GmbH
09366679190
In Commercial Distribution

  • 07613336182987 ()
09366679190

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, control
No Description
Roche Diagnostics GmbH
08924180160
In Commercial Distribution

  • 07613336170212 ()
08924180160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
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