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 System One 60 Series, Canada
Respironics, Inc.
BiPAP autoSV Advanced 60 Series, CA
In Commercial Distribution

  • 00606959029606 ()
CA961S

  • Portable electric ventilator
DreamStation BiPAP autoSV with Humidifier, Canada
Respironics, Inc.
DreamStation BiPAP autoSV w/Humidifier, CA
In Commercial Distribution

  • 00606959040557 ()
CAX900H12

  • Portable electric ventilator
REMstar SE with SD Slot, Canada
Respironics, Inc.
REMstar SE with SD Slot, CA
In Commercial Distribution

  • 00606959038363 ()
221CA

  • Home CPAP unit
  • Heated respiratory humidifier
REMstar Pro C-Flex+, System One 60 Series, Canada
Respironics, Inc.
REMstar Pro C-Flex+, 60 Series, CA
In Commercial Distribution

  • 00606959030145 ()
CA461S

  • Home CPAP unit
The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Beckman Coulter, Inc.
387620
In Commercial Distribution

  • 15099590231859 ()
387620

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
No Description
BIOTECHNOLOGY INSTITUTE SL
IIPEXCA4285
In Commercial Distribution

  • 08435389825845 ()
IIPEXCA4285

  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIPEXCA4275
In Commercial Distribution

  • 08435389825838 ()
IIPEXCA4275

  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIPEXCA4265
In Commercial Distribution

  • 08435389825821 ()
IIPEXCA4265

  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIPEXCA4085
In Commercial Distribution

  • 08435389825425 ()
IIPEXCA4085

  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIPEXCA4075
In Commercial Distribution

  • 08435389825418 ()
IIPEXCA4075

  • Screw endosteal dental implant, two-piece
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