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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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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.
3515
In Commercial Distribution

  • 00301933515013 ()
84450392

  • Self-care monitoring/reporting software
SENTINEL SOFTWARE V11
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
In Commercial Distribution

  • 10841522125751 ()
98201

  • Cardiology information system application software
Actiware Software CD
Respironics, Inc.
Actiware Software CD - 6
In Commercial Distribution

  • 00606959021457 ()
1104775

  • Kinesiology ambulatory recorder
EncorePro 2, Software
Respironics, Inc.
2.21
In Commercial Distribution

  • 00606959048348 ()
1054785

  • Medical equipment clinical data interfacing software
Software, EncorePro2, web
Respironics, Inc.
2.21
In Commercial Distribution

  • 00606959048331 ()
1099731

  • Medical equipment clinical data interfacing software
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
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