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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NDDR version 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution

  • 00812747010217 ()


  • Clinical laboratory information system application software
Donor Doc version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010200 ()


  • Configurable electronic form web-based application software
Symphony version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010194 ()


  • Blood bank information system application software
Surround version 5.x.x
HAEMONETICS CORPORATION
5.x.x
In Commercial Distribution

  • 00812747010170 ()


  • Blood bank information system application software
ElDorado Donor version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010149 ()


  • Blood bank information system application software
ElDorado Donor 2.x.x
HAEMONETICS CORPORATION
2.x.x
In Commercial Distribution

  • 00812747010132 ()


  • Blood bank information system application software
McKesson Blood Bank version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010118 ()


  • Blood bank information system application software
InstaMatch version 1.X.X
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution

  • 00812747010088 ()


  • Blood bank information system application software
CDCS version 1.x.x
HAEMONETICS CORPORATION
1.x.x
In Commercial Distribution

  • 00812747010064 ()


  • Clinical laboratory information system application software
NextGen version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010057 ()


  • Blood bank information system application software
SafeTrace Tx version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010033 ()


  • Blood bank information system application software
BloodSafe version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010019 ()


  • Clinical laboratory information system application software
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
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
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 110 volts
INTRA-LOCK INTERNATIONAL, INC.
ISD110
In Commercial Distribution

  • D742ISD1100 ()
ISD110

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

  • D742ISD2200 ()
ISD220

  • Haematological concentrate system
Leuko-Trol RBC Control Cells
Beckman Coulter, Inc.
RBC Control
In Commercial Distribution

  • 15099590639396 ()
175658

  • Full blood count IVD, control
PXP Disposable Cartridge
Thermogenesis Corp.
80088
In Commercial Distribution

  • 00886368000155 ()
  • 00886368001015 ()


  • Blood centrifugation system containment kit
PXP Disposable Cartridge
Thermogenesis Corp.
80088
In Commercial Distribution

  • 00886368000971 ()


  • Blood centrifugation system containment kit
PXP Disposable Cartridge
Thermogenesis Corp.
80087
In Commercial Distribution

  • 00886368000155 ()
  • 00886368000964 ()


  • Blood centrifugation system containment kit
AXP Accessory
Thermogenesis Corp.
8-5104
In Commercial Distribution

  • 00886368000520 ()
8-5104

  • Cryobiological storage container
No Description
Thermogenesis Corp.
8-5114
In Commercial Distribution

  • 00886368000445 ()
8-5114

  • Cryobiological storage container
PXP Disposable Cartridge
Thermogenesis Corp.
80063
In Commercial Distribution

  • 00886368000605 ()
  • 00886368000711 ()


  • Blood centrifugation system containment kit
PXP Docking Station
Thermogenesis Corp.
80066
In Commercial Distribution

  • 00886368000643 ()
  • 00886368000650 ()


  • Blood centrifugation system containment kit
PXP Control Module
Thermogenesis Corp.
80065
In Commercial Distribution

  • 00886368000629 ()
  • 00886368000636 ()


  • Blood centrifugation system containment kit
No Description
Thermogenesis Corp.
8-5144
In Commercial Distribution

  • 00886368000568 ()
8-5144

  • Cryobiological storage container
Thermogenesis Start Up Accessory Kit, AXP
Thermogenesis Corp.
8-5100
In Commercial Distribution

  • 00886368000544 ()


  • Blood centrifugation system containment kit
AXP Accessory
Thermogenesis Corp.
8-5148
In Commercial Distribution

  • 00886368000537 ()
8-5148

  • Cryobiological storage container
AXP Accessory
Thermogenesis Corp.
7-00-288
In Commercial Distribution

  • 00886368000513 ()
7-00-288

  • Cryobiological storage container
No Description
Thermogenesis Corp.
8-5155
In Commercial Distribution

  • 00886368000438 ()
8-5155

  • Cryobiological storage container
No Description
Thermogenesis Corp.
8-5113
In Commercial Distribution

  • 00886368000421 ()
8-5113

  • Cryobiological storage container
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
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