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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 - 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 - 00606959028470

DreamStation CPAP with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation CPAP w/Humidifier, w/Heated Tube, LA
Not in Commercial Distribution

  • 00606959028470 ()
LAX200T15

  • Home CPAP unit

DreamWear - 00606959026933

DreamWear Pillows, Medium, with Small Frame with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, M, Sm Frame w/Headgear, Global
In Commercial Distribution

  • 00606959026933 ()
1125019

  • CPAP/BPAP nasal mask, reusable

DreamStation - 00606959025950

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

  • 00606959025950 ()
INX700T15

  • Home BPAP 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

FITLIFE - 00606959023055

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

  • 00606959023055 ()
1061711

  • CPAP/BPAP face mask, reusable

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
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