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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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AF531 Mask with Entrainment Elbow, Leak 2, with CapStrap, Single Use, Medium
Respironics, Inc.
AF531 Mask EE, Leak 2, w/CapStrap, Medium, SU
In Commercial Distribution

  • 30606959007377 ()
  • 00606959007376 ()
1119019

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, Nebulizing Elbow, with CapStrap, Single Use, Large
Respironics, Inc.
00606959007352
Not in Commercial Distribution

  • 30606959007353 ()
  • 00606959007352 ()
1119017

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, Nebulizing Elbow, with CapStrap, Single Use, Small
Respironics, Inc.
AF531 Mask w/SE, Nebulizing Elbow, w/CapStrap, Small, SU
Not in Commercial Distribution

  • 30606959007339 ()
  • 00606959007338 ()
1119015

  • CPAP/BPAP face mask, single-use
AF531 Mask with Entrainment Elbow, LEAK 1, with CapStrap, Medium, Single Use
Respironics, Inc.
AF531 Mask EE, LEAK 1, with CapStrap, Medium, Single Use
In Commercial Distribution

  • 30606959004598 ()
  • 00606959004597 ()
1119010

  • CPAP/BPAP face mask, single-use
Adult Nasal Pressure Monitoring Cannula with 7' (2.1 m) tube with filter.
SALTER LABS
5011-7
In Commercial Distribution

  • 10607411500135 ()
  • 00607411500138 ()

  • Adult
5011-7

  • Respiratory apnoea monitoring system
Adult Nasal Pressure Monitoring Cannula with 1' (.3 m) tube with filter.
SALTER LABS
5011-1
In Commercial Distribution

  • 10607411007979 ()
  • 00607411007972 ()
  • 20607411007419 ()

  • Adult
5011-1

  • Respiratory apnoea monitoring system
Adult Nasal Pressure Monitoring Cannula with 2' (.6 m) tube with filter.
SALTER LABS
5011-2
In Commercial Distribution

  • 10607411007962 ()
  • 00607411007965 ()

  • Adult
5011-2

  • Respiratory apnoea monitoring system
DreamWear Under the Nose Nasal Mask, with Medium Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, M Frame w/Headgr, Global
In Commercial Distribution

  • 00606959030916 ()
1116700

  • CPAP/BPAP nasal mask, reusable
DreamStation Auto BiPAP with Humidifier, with Heated Tube, and Cellular Modem, USA
Respironics, Inc.
DreamStation Auto BiPAP w/Humid w/H Tube, w/Cell, US
In Commercial Distribution

  • 00606959025707 ()
DSX700T11C

  • Home BPAP unit
AF541 Mask with Entrainment Elbow, Leak 2, with Four Point Headgear, Large
Respironics, Inc.
AF541 Mask EE, Leak 2 with 4-Point Headgear, Large
In Commercial Distribution

  • 30606959024541 ()
  • 00606959024540 ()
1121068

  • CPAP/BPAP face mask, single-use
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