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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No Description
Thermogenesis Corp.
8-5112
In Commercial Distribution

  • 00886368000414 ()
8-5112

  • Cryobiological storage container
No Description
Thermogenesis Corp.
8-5105
In Commercial Distribution

  • 00886368000407 ()
8-5105

  • Cryobiological storage container
Start-up kit for the AXP System
Thermogenesis Corp.
8-5100
In Commercial Distribution

  • 00886368000377 ()
8-5100

  • Cryobiological storage container
Cord blood processing system docking station
Thermogenesis Corp.
8-5103
In Commercial Distribution

  • 00886368000360 ()
  • 10886368000367 ()
8-5103

  • Cryobiological storage container
Cord blood processing system
Thermogenesis Corp.
8-5102
In Commercial Distribution

  • 00886368000346 ()
  • 10886368000343 ()
8-5102

  • Cryobiological storage container
Utilized for quality control testing of the AXP Device.
Thermogenesis Corp.
70176
In Commercial Distribution

  • 20886368000326 ()
  • 10886368000329 ()
  • 00886368000322 ()
8-5110

  • Cryobiological storage container
Cord blood processing system and storage container
Thermogenesis Corp.
8-5101
In Commercial Distribution

  • 10886368000305 ()
  • 00886368000308 ()


  • Cryobiological storage container
Freezing Bag Set
Thermogenesis Corp.
80135
In Commercial Distribution

  • 00886368000285 ()
  • 00886368000292 ()
80135

  • Blood centrifugation system containment kit
PXP-LAVARE Docking Station, packaged
Thermogenesis Corp.
80122
In Commercial Distribution

  • 00886368000223 ()
  • 00886368000162 ()


  • Blood centrifugation system containment kit
PXP-LAVARE Control Module, packaged
Thermogenesis Corp.
80121
In Commercial Distribution

  • 00886368000216 ()
  • 00886368000179 ()


  • Blood centrifugation system containment kit
PXP-LAVARE Disposable Cartridge
Thermogenesis Corp.
80120
In Commercial Distribution

  • 00886368000209 ()
  • 00886368000155 ()


  • Blood centrifugation system containment kit
PXP-LAVARE Disposable Cartridge
Thermogenesis Corp.
80118
In Commercial Distribution

  • 00886368000193 ()
  • 00886368000155 ()


  • Blood centrifugation system containment kit
PXP-LAVARE Disposable Cartridge
Thermogenesis Corp.
80118
In Commercial Distribution

  • 00886368000186 ()
  • 00886368000155 ()


  • Blood centrifugation system containment kit
PXP-1000 Disposable Cartridge
Thermogenesis Corp.
80102
In Commercial Distribution

  • 00886368000124 ()


  • Blood centrifugation system containment kit
PXP-1000 Disposable Cartridge
Thermogenesis Corp.
80102
In Commercial Distribution

  • 00886368000087 ()
  • 00886368000117 ()


  • Blood centrifugation system containment kit
PXP-1000 Disposable Cartridge
Thermogenesis Corp.
80101
In Commercial Distribution

  • 00886368000100 ()
  • 00886368000087 ()


  • Blood centrifugation system containment kit
PXP-1000 Disposable Cartridge
Thermogenesis Corp.
80100
In Commercial Distribution

  • 00886368000094 ()
  • 00886368000087 ()


  • Blood centrifugation system containment kit
PXP-1000 Docking Station
Thermogenesis Corp.
80103
In Commercial Distribution

  • 00886368000070 ()
  • 00886368000063 ()


  • Blood centrifugation system containment kit
PXP-1000 Control Module
Thermogenesis Corp.
80104
In Commercial Distribution

  • 00886368000056 ()
  • 00886368000049 ()


  • Blood centrifugation system containment kit
AXP II Refurbished Device
Thermogenesis Corp.
80056-RFB
In Commercial Distribution

  • 00886368000612 ()
  • 00886368000001 ()
80056-RFB

  • Blood centrifugation system containment kit
IntraSpin 220 volts
INTRA-LOCK INTERNATIONAL, INC.
IS220
In Commercial Distribution

  • D742IS2200 ()
IS220

  • Haematological concentrate system
IntraSpin 110 volts
INTRA-LOCK INTERNATIONAL, INC.
IS110
In Commercial Distribution

  • D742IS1100 ()
IS110

  • Haematological concentrate system
L-PRF Red Cap Blood Collection CAT Tube (9 ml)
INTRA-LOCK INTERNATIONAL, INC.
BVBCTP2_50
In Commercial Distribution

  • D742BVBCTP250 ()
BVBCTP2_50

  • Blood collection set, noninvasive
IntraSpin Tube Holder Replacement
INTRA-LOCK INTERNATIONAL, INC.
BTUBEHOLD
In Commercial Distribution

  • D742BTUBEHOLD1 ()
BTUBEHOLD

  • Haematological concentrate system
IntraSpin Rotor, 110v & 220v
INTRA-LOCK INTERNATIONAL, INC.
BROTOR
In Commercial Distribution

  • D742BROTOR1 ()
BROTOR

  • Haematological concentrate system
IntraSpin Power Cord, 220v
INTRA-LOCK INTERNATIONAL, INC.
BPOWER220
In Commercial Distribution

  • D742BPOWER2201 ()
BPOWER220

  • Haematological concentrate system
IntraSpin Power Cord, 110v
INTRA-LOCK INTERNATIONAL, INC.
BPOWER110
In Commercial Distribution

  • D742BPOWER1101 ()
BPOWER110

  • Haematological concentrate system
IntraSpin Hex Key, 110v & 220v
INTRA-LOCK INTERNATIONAL, INC.
BHEX
In Commercial Distribution

  • D742BHEX1 ()
BHEX

  • Haematological concentrate system
IntraSpin Fuse, IS220
INTRA-LOCK INTERNATIONAL, INC.
BFUSE220
In Commercial Distribution

  • D742BFUSE2201 ()
BFUSE220

  • Haematological concentrate system
IntraSpin Fuse, IS110
INTRA-LOCK INTERNATIONAL, INC.
BFUSE110
In Commercial Distribution

  • D742BFUSE1101 ()
BFUSE110

  • Haematological concentrate system
IntraSpin System Single 220 volts
INTRA-LOCK INTERNATIONAL, INC.
ISS220
In Commercial Distribution

  • D742ISS2200 ()
ISS220

  • Haematological concentrate system
IntraSpin System Single 110 volts
INTRA-LOCK INTERNATIONAL, INC.
ISS110
In Commercial Distribution

  • D742ISS1100 ()
ISS110

  • Haematological concentrate system
IntraSpin System Dual 220 volts
INTRA-LOCK INTERNATIONAL, INC.
ISD220
In Commercial Distribution

  • D742ISD2200 ()
ISD220

  • Haematological concentrate system
IntraSpin System Dual 110 volts
INTRA-LOCK INTERNATIONAL, INC.
ISD110
In Commercial Distribution

  • D742ISD1100 ()
ISD110

  • Haematological concentrate system
No Description
BIOACCESS INC
MH2150
In Commercial Distribution

  • M791MH21500 ()


  • Bone marrow collection/transfusion set
L-PRF White Cap Plain Z Tube (9 ml)
INTRA-LOCK INTERNATIONAL, INC.
WCT_50
In Commercial Distribution

  • D742WCT50 ()
WCT_50

  • Blood collection set, noninvasive
No Description
ESTAR TECHNOLOGIES LTD
06212SC
Not in Commercial Distribution

  • 17290015874202 ()
06212SC

  • Haematological concentrate system preparation kit, platelet concentration
HemoCue Hb 301 Microcuvettes 4x75 vial
Hemocue AB
111814
In Commercial Distribution

  • 27311091118077 ()
  • 17311091118148 ()
111814

  • Haemoglobin analyser IVD, point-of-care
HemoCue Hb 301 Microcuvettes 4x50 vial
Hemocue AB
111801
In Commercial Distribution

  • 07311091118011 ()
  • 17311091118018 ()
  • 27311091118015 ()
111801

  • Haemoglobin analyser IVD, point-of-care
HemoCue Plasma/Low Hb Microcuvettes 4x25 vial
Hemocue AB
110302
In Commercial Distribution

  • 07311091103024 ()
  • 17311091103021 ()
  • 27311091103028 ()
110302

  • Haemoglobin analyser IVD, point-of-care
Red Blood Cell Diluent for TANGO instruments, 10x10 mL
Bio-Rad Medical Diagnostics GmbH
806210100
In Commercial Distribution

  • 07611969965755 ()
806210100

  • Bromelin immunohaematology reagent IVD
Gel card for use with the IH system; Card for antibody detection of human red blood cells; 288 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813612100
In Commercial Distribution

  • 07611969964871 ()
813612100

  • ABO/Rh multiple blood grouping IVD, kit, agglutination
Gel card for use with the IH system; Card for antibody detection of human red blood cells; 12 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813610100
In Commercial Distribution

  • 07611969964864 ()
813610100

  • ABO/Rh multiple blood grouping IVD, kit, agglutination
Instrument
Bio-Rad Medical Diagnostics GmbH
848900010
In Commercial Distribution

  • 07611969961696 ()
848900010

  • Immunohaematology/blood bank analyser IVD
Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823300
Not in Commercial Distribution

  • 07611969952939 ()
823300

  • HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)
No Description
SCC SOFT COMPUTER
25.6.2.0
In Commercial Distribution

  • 00810142371827 ()


  • Blood bank information system application software
Gel card for use with the IH system; Card for antibody detection of human red blood cells; 48 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813611100
In Commercial Distribution

  • 07611969952229 ()
813611100

  • ABO/Rh multiple blood grouping IVD, kit, agglutination
Optional card for the negative control in ABO and Rh typing; 12 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813600100
In Commercial Distribution

  • 07611969952212 ()
813600100

  • Antisera matrix (non-reactive) IVD, control
Microplate for use in detection of red blood cell antibodies and antigens in indirect and direct antiglobulin tests with solid phase antiglobulin technique on TANGO instruments; 10 plates
Bio-Rad Medical Diagnostics GmbH
806521100
In Commercial Distribution

  • 07611969951499 ()
806521100

  • Solid-phase red blood cell adherence antibody/antigen IVD
Positive Control for Solidscreen II on TANGO instruments; 4ml
Bio-Rad Medical Diagnostics GmbH
806519100
In Commercial Distribution

  • 07611969951468 ()
806519100

  • Anti-Rh(D) antibody screen IVD, control
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