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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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RAPIDLab® 1200 Series 1260 - 00630414515564

RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1260 can determine pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate parameters
Siemens Healthcare Diagnostics Inc.
10321846
In Commercial Distribution

  • 00630414515564 ()
5062460

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

DreamStation - 00606959053182

DreamStation Expert with Humidifier and Wifi, for Canada
Respironics, Inc.
DreamStation Expert w/Humidifier, w/WiFi, CA
In Commercial Distribution

  • 00606959053182 ()
CAX501H12W

  • Home CPAP unit

DreamStation - 00606959053175

DreamStation Expert with Humidifier and Cellular modem for Canada
Respironics, Inc.
DreamStation Expert w/Humidifier, w/Cell, CA
In Commercial Distribution

  • 00606959053175 ()
CAX501H12C

  • Home CPAP unit

DreamStation Go - 00606959048614

DreamStation Go Auto CPAP with Bluetooth, Canada
Respironics, Inc.
DreamStation Go Auto CPAP with Bluetooth, CA
In Commercial Distribution

  • 00606959048614 ()
CAG500S12

  • Home CPAP unit

EverFlo - 00606959014954

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

REMstar SE - 00606959036789

REMstar SE Auto with SD Slot, Canada
Respironics, Inc.
REMstar SE Auto with SD Slot, CA
In Commercial Distribution

  • 00606959036789 ()
CA521S

  • Heated respiratory humidifier
  • Home CPAP unit

Millennium M10 - 00606959033191

Millennium M10 Oxygen Percentage Indicator Concentrator, Canada
Respironics, Inc.
Millennium M10 Oxygen Percentage Indicator Concentrator, CA
Not in Commercial Distribution

  • 00606959033191 ()
M10605-80

  • Stationary oxygen concentrator

BiPAP System One 60 Series - 00606959031760

BiPAP Auto BiFlex, BlueTooth, System One 60 Series,Canada
Respironics, Inc.
BiPAP Auto BiFlex, BlueTooth, 60 Series, CA
In Commercial Distribution

  • 00606959031760 ()
CA761BT

  • Home BPAP unit

BiPAP autoSV Advanced System One 60 Series - 00606959029767

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

System One - 00606959029200

System One Heated Humidifier without Tube, Canada
Respironics, Inc.
System One Heated Humidifier without Tube, CA
In Commercial Distribution

  • 00606959029200 ()
CA6NT

  • Heated respiratory humidifier
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