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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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DreamStation - 00606959022515

DreamStation BiPAP Pro with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation BiPAP Pro w/Humidifier, w/H Tube, US
In Commercial Distribution

  • 00606959022515 ()
DSX600T11

  • Home BPAP unit

DreamStation - 00606959022423

DreamStation CPAP Pro with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/Heated Tube, US
In Commercial Distribution

  • 00606959022423 ()
DSX400T11

  • Home CPAP unit

REMstar SE - 00606959012509

REMstar SE with Heated Tube, with SD Slot, US
Respironics, Inc.
REMstar SE with Heated Tube, with SD Slot, US
Not in Commercial Distribution

  • 00606959012509 ()
DS220TS

  • Home CPAP unit
  • Heated respiratory humidifier

DreamStation - 00606959043824

DreamStation CPAP Pro with C Flex with Humidifier, GB
Respironics, Inc.
DreamStation CPAP Pro with C Flex with Humidifier, GB
In Commercial Distribution

  • 00606959043824 ()
GBX401H15

  • Home CPAP unit

Sanibel - 05711117129687

Pouch with 100 electrodes (10 cards with 10 each)
Interacoustics A/S
TAB Electrode
In Commercial Distribution

  • 05711117129687 ()
  • 05711117199055 ()


  • Analytical non-scalp cutaneous electrode

MADA Aerosol Mask Kits - 00709078001970

VixOne Nebulizer with Pediatric Aerosol Mask (With Single Vents)
WESTMED, INC.
50311
In Commercial Distribution

  • 10709078001977 ()
  • 00709078001970 ()


  • Nebulizing system delivery set, single-use

MADA Aerosol Mask Kits - 00709078001963

VixOne Nebulizer with Adult Aerosol Mask (With Single Vents)
WESTMED, INC.
50310
Not in Commercial Distribution

  • 00709078001963 ()
  • 10709078001960 ()


  • Nebulizing system delivery set, single-use

Endoplus - 00817401026047

10mm Babcock with Pyramid Serrations, Standard Handle, With Rotation
Endoplus
E446SR
In Commercial Distribution

  • 00817401026047 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Endoplus - 00817401026030

10mm Babcock with Pyramid Serrations, Ratcheting Handle, With Rotation
Endoplus
E446RR
In Commercial Distribution

  • 00817401026030 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Endoplus - 00817401025446

5mm Maryland with Cross Serrations, Standard Handle, With Rotation
Endoplus
E378SR
In Commercial Distribution

  • 00817401025446 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
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