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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BiPAP autoSV Advanced, 60 Series, 30cm, CAN
Respironics, Inc.
BiPAP autoSV Advanced, 30cm, 60 Series, CA
Not in Commercial Distribution

  • 00606959029767 ()
CA961XS

  • Portable electric ventilator
EverFlo Non-O2 Percentage Indicator, 120V, US,CANADA
Respironics, Inc.
EVERFLO NON-O2 Percentage Indicator, 120V, US,CA
In Commercial Distribution

  • 00606959014954 ()
1020000

  • Stationary oxygen concentrator
System One Heated Humidifier without Tube, Canada
Respironics, Inc.
System One Heated Humidifier without Tube, CA
In Commercial Distribution

  • 00606959029200 ()
CA6NT

  • Heated respiratory humidifier
RAPIDPoint® 500 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an invitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10844813
In Commercial Distribution

  • 00630414947556 ()
10844813

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 500 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10491448
In Commercial Distribution

  • 00630414589763 ()
10491448

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 405/500 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10313971
In Commercial Distribution

  • 00630414477855 ()
130523

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 500 Measurement Cartridge (750 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10491449
In Commercial Distribution

  • 00630414589770 ()
10491449

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 500 Measurement Cartridge (250 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10491447
In Commercial Distribution

  • 00630414589756 ()
10491447

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 405/500 Measurement Cartridge (250 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10283222
In Commercial Distribution

  • 00630414553610 ()
10283222

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human blood. The 1265 can determine pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, FO2Hb, FCOHb, FMetHb, FHHb parameters
Siemens Healthcare Diagnostics Inc.
10321852
In Commercial Distribution

  • 00630414515571 ()
5063769

  • Blood gas/haemoximetry analyser IVD, point-of-care
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