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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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OmniLab Direct Software
Respironics, Inc.
OmniLab Direct Software - 2
In Commercial Distribution

  • 00606959044302 ()
1112033

  • Clinical laboratory information system
EncorePro 2, Software
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959043114 ()
1054785

  • Medical equipment clinical data interfacing software
Software, EncorePro2, web
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959042957 ()
1099731

  • Medical equipment clinical data interfacing software
Software, EncorePro2, web
Respironics, Inc.
2.19
In Commercial Distribution

  • 00606959040434 ()
1099731

  • Medical equipment clinical data interfacing software
myQA Daily Software
IBA Dosimetry GmbH
DQ00000
In Commercial Distribution

  • EIBADQ000000 ()
DQ00-000

  • Accelerator system quality assurance device
myQA iON software
IBA Dosimetry GmbH
MQ10-000
In Commercial Distribution

  • EIBAMQ100000 ()


  • Accelerator system quality assurance device
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3515
In Commercial Distribution

  • 00301933515013 ()
84450392

  • Self-care monitoring/reporting software
UDI Software Pristina
GE MEDICAL SYSTEMS
PRISTINA 2.8.3
In Commercial Distribution

  • 00195278711229 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit
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