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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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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

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 - 00606959034297

DreamStation BiPAP Pro with Humidifier and WiFi, American Home Patient
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, with WiFi, AHP
Not in Commercial Distribution

  • 00606959034297 ()
AHX600H11W

  • Home BPAP unit

AF541 - 00606959024670

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

  • 30606959024671 ()
  • 00606959024670 ()
1121081

  • CPAP/BPAP face mask, single-use

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 - 00606959024656

AF541 Mask with Standard Elbow, with CapStrap, Medium
Respironics, Inc.
AF541 Mask with Standard Elbow, WITH CAPSTRAP, MEDIUM
In Commercial Distribution

  • 30606959024657 ()
  • 00606959024656 ()
1121079

  • 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 - 00606959024632

AF541 Mask with Standard Elbow, with 4 Point Headgear, Extra Large
Respironics, Inc.
AF541 Mask with SE, WITH 4-PT HEADGEAR, X-LARGE
In Commercial Distribution

  • 30606959024633 ()
  • 00606959024632 ()
1121077

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024625

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

  • 30606959024626 ()
  • 00606959024625 ()
1121076

  • 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
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