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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 Mask with Entrainment Elbow, Leak 1, with CapStrap, Medium
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ CAPSTRAP, Medium, US
In Commercial Distribution

  • 30606959024411 ()
  • 00606959024410 ()
1121063

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with CAPSTRAP, Small
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ CAPSTRAP, Small, US
In Commercial Distribution

  • 30606959024404 ()
  • 00606959024403 ()
1121062

  • CPAP/BPAP face mask, single-use
DreamStation Cellular Modem with Oximetry, Europe, with PRI Label, Rental
Respironics, Inc.
DreamStation Cellular Modem with Oximetry, PRI, EU
Not in Commercial Distribution

  • 00606959022867 ()
100620C

  • Medical networking interface unit
Wisp Mask, Clear Frame, with Headgear, with Standard Elbow, International
Respironics, Inc.
Wisp Mask, Clear Frame, with Headgear, w/SE, INTL
In Commercial Distribution

  • 00606959021280 ()
1094062

  • CPAP/BPAP nasal mask, reusable
ComfortGel Blue Mask with Standard Elbow, with Headgear, Petite, International
Respironics, Inc.
ComfortGel Blue Mask w/SE, w/Headgear, Petite, INTL
In Commercial Distribution

  • 00606959020832 ()
1070071

  • CPAP/BPAP nasal mask, reusable
AF541 Mask with Standard Elbow, with Capstrap, Size Small, Japan
Respironics, Inc.
AF541 Mask with Standard Elbow, with Capstrap, Small, JP
Not in Commercial Distribution

  • 30606959041357 ()
  • 00606959041356 ()
1129504

  • CPAP/BPAP face mask, single-use
DreamStation AVAPS 30 AE with Humidifier, with Heated Tube, Australia
Respironics, Inc.
DreamStation BiPAP AVAPS 30 AE w/Humid w/H Tube, AU
In Commercial Distribution

  • 00606959041066 ()
AUX1131T15

  • Portable electric ventilator
DreamStation BiPAP AVAPS 30 with humidifier, with heated tubing, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 AAM w/Humid w/H Tube, CA
In Commercial Distribution

  • 00606959040922 ()
CAX1130T12

  • Portable electric ventilator
DreamStation BiPAP AVAPS 30 with Humidifier, with Heated Tubing, USA
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/Humid w/H Tube,US
In Commercial Distribution

  • 00606959040892 ()
DSX1130T11

  • Portable electric ventilator
Wisp Mask, with Standard Elbow, Clear Frame, with Headgear, China
Respironics, Inc.
Wisp Mask, w/SE, Clear Frame, with Headgear, China
Not in Commercial Distribution

  • 00606959040106 ()
1109312

  • CPAP/BPAP nasal mask, reusable
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