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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 - 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

AF541 - 00606959041370

AF541 Mask with Standard Elbow with Capstrap, Size Large, Japan
Respironics, Inc.
AF541 Mask with SE, with Capstrap, Large, JP
Not in Commercial Distribution

  • 30606959041371 ()
  • 00606959041370 ()
1129506

  • CPAP/BPAP face mask, single-use

AF541 - 00606959041363

AF541 Mask with Standard Elbow with Capstrap, Size Medium, Japan
Respironics, Inc.
AF541 Mask with SE, with Capstrap, Medium, JP
Not in Commercial Distribution

  • 30606959041364 ()
  • 00606959041363 ()
1129505

  • CPAP/BPAP face mask, single-use

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

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 - 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
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