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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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HUMAC Biodex System4 - 00860139000360

HUMAC Biodex System4 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503680
In Commercial Distribution

  • 00860139000360 ()
503680

  • Back/leg/chest dynamometer

HUMAC Biodex System3 Rev1 (R) - 00860139000353

HUMAC Biodex System3 Rev1 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503679
In Commercial Distribution

  • 00860139000353 ()
503679

  • Back/leg/chest dynamometer

HUMAC Biodex System3 Rev0 (R) - 00860139000346

HUMAC Biodex System3 Rev0 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503678
In Commercial Distribution

  • 00860139000346 ()
503678

  • Back/leg/chest dynamometer

HUMAC Biodex System2 (R) - 00860139000339

HUMAC Biodex System2 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503677
In Commercial Distribution

  • 00860139000339 ()
503677

  • Back/leg/chest dynamometer

HUMAC Cybex NORM (R) - 00860139000322

HUMAC Cybex NORM Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
504192
In Commercial Distribution

  • 00860139000322 ()
504192

  • Back/leg/chest dynamometer

HUMAC NORM (R) - 00860139000315

HUMAC NORM Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
504191
In Commercial Distribution

  • 00860139000315 ()
504191

  • Back/leg/chest dynamometer

HUMAC NORM - 00860139000308

HUMAC NORM Extremity System; Dynamometer
COMPUTER SPORTS MEDICINE INC.
502140
In Commercial Distribution

  • 00860139000308 ()
502140-00

  • Back/leg/chest dynamometer

BBCS Lab Interface Application V5.0 - 00860009119482

No Description
Blood Bank Computer System
5.0
In Commercial Distribution

  • 00860009119482 ()


  • Blood bank information system application software

Blood Bank Control System, V5.0 - 00860009119475

No Description
Blood Bank Computer System
5.0
In Commercial Distribution

  • 00860009119475 ()


  • Blood bank information system application software

BBCS Hospital Interface Application - 00860009119468

No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119468 ()


  • Blood bank information system application software

ABO QuickPass V 1.0.0 - 00860009119444

ABO QuickPass is a software application intended to allow donors to complete Computer Assisted Self Interviews (CASI) and computer assisted blood donor registrations. ABO QuickPass works in tandem with compatible blood bank systems to identify repeat donors, retrieve the donor’s donation eligibility, and retrieve the donor history questionnaire appropriate for the donor and intended donation. Upon completion of ABO QuickPass all information which is entered by the donor is transferred to compatible blood bank systems. CASIs can be completed using the Internet via the ABO QuickPass web portal or at the donor site via the ABO QuickPass kiosk. CASIs which are completed via the web portal produce an encrypted barcode, which can be decrypted and imported on the day of donation into the ABO QuickPass kiosk for transfer of question responses to the facilities compatible blood bank system
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119444 ()


  • Blood bank information system application software

BBCS BloodTrack Interface Application - 00860009119451

No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119451 ()


  • Blood bank information system application software

ABO Wheels V 1.0.0 - 00860009119437

No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119437 ()


  • Blood bank information system application software

Blood Bank Control System 6.0 - 00860009119420

No Description
Blood Bank Computer System
6.0
In Commercial Distribution

  • 00860009119420 ()


  • Blood bank information system application software

ABO Express V 2.0.0 - 00860009119406

No Description
Blood Bank Computer System
2.0.0
In Commercial Distribution

  • 00860009119406 ()


  • Blood bank information system application software

OBIX Perinatal Data System - 00868102000447

OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Triage). A patient record is populated with information related to perinatal fetal monitor surveillance.
Clinical Computer Systems, Inc.
9.0
In Commercial Distribution

  • 00868102000447 ()


  • Patient health record information system application software

OBIX Perinatal Data System - 00868102000423

OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Triage). A patient record is populated with information related to perinatal fetal monitor surveillance.
Clinical Computer Systems, Inc.
8.1
In Commercial Distribution

  • 00868102000423 ()


  • Patient health record information system application software

OBIX Perinatal Data System - 00868102000416

OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Triage). A patient record is populated with information related to perinatal fetal monitor surveillance.
Clinical Computer Systems, Inc.
10.0
In Commercial Distribution

  • 00868102000416 ()


  • Patient health record information system application software

Leica CytoVision Karyotyping review software (inc. dongle) - 00849832003656

Leica CytoVision Karyotyping review software (incl. dongle)
Leica Biosystems Richmond, Inc.
23SWR000KXX001
Not in Commercial Distribution

  • 00849832003656 ()

  • Device Size Text, specify:


  • Laboratory analyser operation system software IVD

FACSCanto - 00382906641267

BD FACSCanto™ System Software
Becton, Dickinson And Company
664126
In Commercial Distribution

  • 00382906641267 ()
664126

  • Laboratory analyser operation system software IVD

FACSCanto - 00382906641243

BD FACSCanto™ II System Software
Becton, Dickinson And Company
664124
In Commercial Distribution

  • 00382906641243 ()
664124

  • Laboratory analyser operation system software IVD

FACSCanto - 00382906641229

BD FACSCanto™ System Software
Becton, Dickinson And Company
664122
In Commercial Distribution

  • 00382906641229 ()
664122

  • Laboratory analyser operation system software IVD

FACSCanto - 00382906641199

BD FACSCanto™ Clinical Software v4.0.1
Becton, Dickinson And Company
664119
In Commercial Distribution

  • 00382906641199 ()
664119

  • Laboratory analyser operation system software IVD

BD FACSDiva - 00382906641182

BD FACSDiva™ Software v9.0
Becton, Dickinson And Company
664118
In Commercial Distribution

  • 00382906641182 ()
664118

  • Laboratory analyser operation system software IVD

FACS - 00382906641168

BD FACS™ Sample Prep Assistant III Software v6.0
Becton, Dickinson And Company
664116
In Commercial Distribution

  • 00382906641168 ()
664116

  • Laboratory analyser operation system software IVD

FACSCanto - 00382906641144

BD FACSCanto™ System Software
Becton, Dickinson And Company
664114
In Commercial Distribution

  • 00382906641144 ()
664114

  • Laboratory analyser operation system software IVD

FACSCanto - 00382906641120

BD FACSCanto™ System Software
Becton, Dickinson And Company
664112
In Commercial Distribution

  • 00382906641120 ()
664112

  • Laboratory analyser operation system software IVD

FACSCanto - 00382906641106

BD FACSCanto™ II System Software
Becton, Dickinson And Company
664110
In Commercial Distribution

  • 00382906641106 ()
664110

  • Laboratory analyser operation system software IVD

BD Multiset™ - 00382903431786

Simulset V3.1 Update Kit
BECTON, DICKINSON AND COMPANY
343178
Not in Commercial Distribution

  • 00382903431786 ()
343178

  • Laboratory analyser operation system software IVD

ASI IVD System - 07290016630046

ASI IVD System with software version GenASIs V-8.4
APPLIED SPECTRAL IMAGING LTD.
GenASIs 8.4
In Commercial Distribution

  • 07290016630046 ()


  • Laboratory analyser operation system software IVD

ASI IVD System - 07290016630039

ASI IVD System with software version GenASIs V-8.3
APPLIED SPECTRAL IMAGING LTD.
GenASIs 8.3
In Commercial Distribution

  • 07290016630039 ()


  • Laboratory analyser operation system software IVD

GenASIs™ System - 07290016630015

No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630015 ()


  • Laboratory analyser operation system software IVD

GenASIs™ System - 07290016630008

No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630008 ()


  • Laboratory analyser operation system software IVD

m2000 - 00884999043503

m2000rt SYSTEM SOFTWARE Release 8.0
ABBOTT MOLECULAR INC.
08N89-001
In Commercial Distribution

  • 00884999043503 ()
08N89-001

  • Laboratory analyser operation system software IVD

LiDCO - 00843997017435

LiDCO Module, L, 1/Box
MASIMO CORPORATION
95099
In Commercial Distribution

  • 00843997017190 ()
  • 00843997017435 ()


  • General-purpose multi-parameter bedside monitor

LiDCO - 00843997017428

Kit, LiDCO Module, L
MASIMO CORPORATION
95098
In Commercial Distribution

  • 00843997017190 ()
  • 00843997017428 ()


  • General-purpose multi-parameter bedside monitor

LiDCO - 00843997002882

Kit, LiDCO Module
MASIMO CORPORATION
95060
In Commercial Distribution

  • 00843997017190 ()
  • 00843997002882 ()


  • General-purpose multi-parameter bedside monitor

LiDCO - 00843997001823

LiDCO Module
MASIMO CORPORATION
95059
In Commercial Distribution

  • 00843997017190 ()
  • 00843997001823 ()


  • General-purpose multi-parameter bedside monitor

LiDCO - 05060110523092

Licence, Software, LiDCOunity (Rapid, Plus, Li, BIS, CNAP, Ext, Prod Sw), Quarterly
LIDCO LIMITED
Li11079Q
In Commercial Distribution

  • 05060110523092 ()
Li11079Q

  • General-purpose multi-parameter bedside monitor

LiDCO - 05060110523085

Licence, Software, LiDCOunity (Rapid, Plus, Li, BIS, CNAP, Ext, Prod Sw), Monthly
LIDCO LIMITED
Li11079M
In Commercial Distribution

  • 05060110523085 ()
Li11079M

  • General-purpose multi-parameter bedside monitor
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