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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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 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 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
REMstar Plus, with Humidifier, System One 60 Series, Canada
Respironics, Inc.
REMstar Plus, with Humidifier, 60 Series, CA
Not in Commercial Distribution

  • 00606959030060 ()
CA261HS

  • Home CPAP unit
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
No Description
Slmp, LLC
(BTO) Sample CA 15-3 (DBMM1) Antibody (2ml)
In Commercial Distribution

  • 00810170552496 ()
SAM-MM12-2

  • Cancer antigen 15-3 (CA15-3) IVD, antibody
Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/6 Prone Face Cushion Dual Chest Pillows 4 Hip Thigh Covers Set Of 4 Arm Cradles Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49455
In Commercial Distribution

  • 20885632448499 ()
  • 10885632448492 ()


  • Freestanding patient positioner, single-use
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
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