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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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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 - 00606959022485

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

  • 00606959022485 ()
DSX500T11

  • Home CPAP 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 - 00606959020085

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

  • 00606959020085 ()
CA221TS

  • Heated respiratory humidifier
  • 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

PERFORMATRAK - 00606959007567

PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, LARGE
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, LARGE
In Commercial Distribution

  • 30606959007568 ()
  • 00606959007567 ()
1048719

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959007550

PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, MEDIUM
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, MEDIUM
In Commercial Distribution

  • 30606959007551 ()
  • 00606959007550 ()
1048720

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959007543

PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, SMALL
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, SMALL
In Commercial Distribution

  • 30606959007544 ()
  • 00606959007543 ()
1048721

  • CPAP/BPAP face mask, single-use
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