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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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Alinity m - 00884999048676

Alinity m HR HPV Application Specification File
ABBOTT MOLECULAR INC.
09N15-03A
In Commercial Distribution

  • 00884999048676 ()
09N15-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048669

Alinity m STI Application Specification File
ABBOTT MOLECULAR INC.
09N17-03A
In Commercial Distribution

  • 00884999048669 ()
09N17-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048652

Alinity m HCV Application Specification File
ABBOTT MOLECULAR INC.
08N50-03A
In Commercial Distribution

  • 00884999048652 ()
08N50-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048645

Alinity m HBV Application Specification File
ABBOTT MOLECULAR INC.
08N47-03A
In Commercial Distribution

  • 00884999048645 ()
08N47-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048638

Alinity m HIV-1 Application Specification File
ABBOTT MOLECULAR INC.
08N45-03A
In Commercial Distribution

  • 00884999048638 ()
08N45-03A

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999048065

Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
06L83-008
In Commercial Distribution

  • 00884999048065 ()
06L83-008

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999047792

Abbott RealTime IDH1m2000rt Application CD-ROM
ABBOTT MOLECULAR INC.
08N90-006
In Commercial Distribution

  • 00884999047792 ()
08N90-006

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999047297

Abbott RealTime CMV m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
09N21-002
In Commercial Distribution

  • 00884999047297 ()
09N21-002

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999047068

Abbott RealTime ZIKA Application CD-ROM
ABBOTT MOLECULAR INC.
09N27-002
In Commercial Distribution

  • 00884999047068 ()
09N27-002

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999047037

Abbott RealTime IDH2 m2000rt Application CD-ROM
ABBOTT MOLECULAR INC.
08N82-001
In Commercial Distribution

  • 00884999047037 ()
08N82-001

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999042704

Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
06L83-007
Not in Commercial Distribution

  • 00884999042704 ()
06L83-007

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999042681

Abbott RealTime HCV m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
04N45-004
In Commercial Distribution

  • 00884999042681 ()
04N45-004

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999042667

Abbott RealTime HBV m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
02N43-004
In Commercial Distribution

  • 00884999042667 ()
02N43-004

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999042513

Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
08L21-002
In Commercial Distribution

  • 00884999042513 ()
08L21-002

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999037762

Abbott RealTime HBV m2000 System Combined Application CD-ROM, Version 3.0
ABBOTT MOLECULAR INC.
2N43-03
In Commercial Distribution

  • 00884999037762 ()
2N43-03

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999037656

Abbott RealTime HCV m2000 System Combined Application CD-ROM, Version 3.0
ABBOTT MOLECULAR INC.
4N45-03
In Commercial Distribution

  • 00884999037656 ()
4N45-03

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999037168

Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM, Version 6.0
ABBOTT MOLECULAR INC.
6L83-06
In Commercial Distribution

  • 00884999037168 ()
6L83-06

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999037113

Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version 5.0
ABBOTT MOLECULAR INC.
06L98-05
In Commercial Distribution

  • 00884999037113 ()
06L98-05

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999034266

Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM, Version 1.0
ABBOTT MOLECULAR INC.
08L21-01
In Commercial Distribution

  • 00884999034266 ()
08L21-01

  • Laboratory instrument/analyser application software IVD

INTEllIO LINK WEREWOLF - 00885556741641

INTELLIO LINK WEREWOLF
Smith & Nephew, Inc.
72205191
In Commercial Distribution

  • 00885556741641 ()
72205191

  • Operating room audiovisual data/device management system application software

LINK DOUBLEFLOW PUMP - 00885556741634

LINK DOUBLEFLO PUMP
Smith & Nephew, Inc.
72205190
In Commercial Distribution

  • 00885556741634 ()
72205190

  • Operating room audiovisual data/device management system application software

INTELLIO LINK Dyonics Power II - 00885556741627

INTELLIO LINK DYONICS POWER II
Smith & Nephew, Inc.
72205189
In Commercial Distribution

  • 00885556741627 ()
72205189

  • Operating room audiovisual data/device management system application software

Caption - 00198953030233

Caption AI on Vscan
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
AI
In Commercial Distribution

  • 00198953030233 ()


  • Ultrasound imaging system application software

Venue Sprint - 00198953001387

Venue Sprint R6 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R6
In Commercial Distribution

  • 00198953001387 ()


  • Ultrasound imaging system application software

McKesson Anesthesia Care - 80010939010014

No Description
MCKESSON TECHNOLOGIES INC.
15.2
In Commercial Distribution

  • 80010939010014 ()


  • Anaesthesia information system application software

HeRO solo - 00865536000227

A HeRO System for the private room
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000227 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO symphony - 00865536000203

Server based HeRO System
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000203 ()


  • Neonatal/paediatric heart rate monitoring hardware
  • Neonatal/paediatric heart rate monitoring application software

HeRO duet - 00865536000234

A standalone HeRO monitor for two infants
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000234 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO ES - 00865536000210

No Description
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000210 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

InferRead Lung CT.AI - 00850003095042

InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest.
Infervision Medical Technology Co., Ltd
5.0.2.5
In Commercial Distribution

  • 00850003095042 ()


  • X-ray image interpretive software
  • Diagnostic x-ray digital imaging system workstation
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