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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 - 00606959025868

DreamStation CPAP Pro with Humidifier, with Heated Tube, International
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/H Tube, INTL
In Commercial Distribution

  • 00606959025868 ()
INX400T15

  • Home CPAP unit

FITLIFE - 00606959023093

FitLife Mask with Headgear, with Standard Elbow, Large, Japan
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Large, Japan
Not in Commercial Distribution

  • 00606959023093 ()
1061714

  • CPAP/BPAP face mask, reusable

FITLIFE - 00606959023086

FitLife Mask with Headgear, with Standard Elbow, Small, Japan
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Small, Japan
In Commercial Distribution

  • 00606959023086 ()
1061713

  • CPAP/BPAP face mask, reusable

FITLIFE - 00606959023062

FitLife Mask with Headgear, with Standard Elbow, Large, International
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Large, INTL
In Commercial Distribution

  • 00606959023062 ()
1061712

  • CPAP/BPAP face mask, reusable

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

Health o meter professional - 00851628008363

Wheelchair Scale with Fold Seat, KG only with BT
Pelstar, LLC
2500CKG-BT
In Commercial Distribution

  • 00851628008363 ()


  • Wheelchair-accessible platform scale
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