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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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AF541 - 00606959024601

AF541 Mask with Standard Elbow, with 4 Point Headgear, Small
Respironics, Inc.
AF541 Mask with SE, WITH 4-PT HEADGEAR, SMALL
In Commercial Distribution

  • 30606959024602 ()
  • 00606959024601 ()
1121074

  • CPAP/BPAP face mask, single-use

FitLife - 00606959023109

FitLife Mask with Standard Elbow, with Headgear, Extra Large, Japan
Respironics, Inc.
FitLife Mask with SE, with Headgear, XLarge, JP
Not in Commercial Distribution

  • 00606959023109 ()
1089997

  • CPAP/BPAP face mask, reusable

FitLife - 00606959023079

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

  • 00606959023079 ()
1089995

  • CPAP/BPAP face mask, reusable

REMstar SE - 00606959036918

REMstar SE with Humidifier, with SD Slot, International
Respironics, Inc.
REMstar SE with HUMIDIFIER, with SD Slot, INTL
In Commercial Distribution

  • 00606959036918 ()
IN221HS

  • Home CPAP unit
  • Heated respiratory humidifier

DreamStation - 00606959025516

DreamStation BiPAP Pro with Humidifier and Cellular Modem, American Home Patient (AHP)
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, with Cell, AHP
Not in Commercial Distribution

  • 00606959025516 ()
AHX600H11C

  • Home BPAP unit

AF541 - 00606959024663

AF541 Mask with Standard Elbow, with CapStrap, Large
Respironics, Inc.
AF541 Mask with Standard Elbow, WITH CAPSTRAP, LARGE
In Commercial Distribution

  • 30606959024664 ()
  • 00606959024663 ()
1121080

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024649

AF541 Mask with Standard Elbow, with CapStrap, Small
Respironics, Inc.
AF541 Mask with Standard Elbow, WITH CAPSTRAP, SMALL
In Commercial Distribution

  • 30606959024640 ()
  • 00606959024649 ()
1121078

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024618

AF541 Mask with Standard Elbow, with 4 Point Headgear, Medium
Respironics, Inc.
AF541 Mask with SE, WITH 4-PT HEADGEAR, MEDIUM
In Commercial Distribution

  • 30606959024619 ()
  • 00606959024618 ()
1121075

  • CPAP/BPAP face mask, single-use

REMstar SE - 00606959020078

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

  • 00606959020078 ()
CA221HS

  • Heated respiratory humidifier
  • Home CPAP unit

REMstar SE - 00606959020047

REMstar SE with Humidifier, with SD Slot, AH
Respironics, Inc.
REMstar SE with Humidifier, with SD Slot, AH
Not in Commercial Distribution

  • 00606959020047 ()
AH220HS

  • Home CPAP unit
  • Heated respiratory humidifier
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