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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, with 4 Point Headgear, Large, USA
Respironics, Inc.
AF531 Mask EE with 4 point Headgear, Large, USA
In Commercial Distribution

  • 30606959012241 ()
  • 00606959012240 ()
1094801

  • CPAP/BPAP face mask, single-use
PerformaTrak Full Mask with Standard Elbow, with CapStrap, Single Use, MEDIUM
Respironics, Inc.
PerformaTrak Full Mask, Medium, w/SE and CapStrap, SU
In Commercial Distribution

  • 00606959011618 ()
1063897

  • CPAP/BPAP face mask, single-use
PerformaTrak Full Mask with Standard Elbow, with CapStrap, Single Use, SMALL
Respironics, Inc.
PerformaTrak Full Mask, Small, w/SE w/CapStrap, SU
In Commercial Distribution

  • 00606959011601 ()
1063836

  • CPAP/BPAP face mask, single-use
DreamWear Full Mask, Medium Wide, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Full Mask Medium Wide, w/Large Frame w/Headgear, Global
In Commercial Distribution

  • 00606959046146 ()
1133393

  • CPAP/BPAP nasal mask, reusable
DreamWear Full Mask, Medium Wide, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Full Mask Medium Wide, w/Small Frame w/Headgear, Global
In Commercial Distribution

  • 00606959046108 ()
1133388

  • CPAP/BPAP nasal mask, reusable
DreamWear Full Mask, Medium Wide, with Medium Frame with Headgear, Global
Respironics, Inc.
DreamWear Full Mask Medium Wide, w/Medium Frame w/Headgear, Global
In Commercial Distribution

  • 00606959046061 ()
1133383

  • CPAP/BPAP nasal mask, reusable
Adult. Oral/Nasal Pressure Monitoring Cannula with 7' tube with filter.
SALTER LABS
SO-2054
In Commercial Distribution

  • 01060741194061 ()
  • 00607411940675 ()

  • Adult
DM7100

  • Nasal oxygen cannula, basic
Comfort Face Tent with 42” Aerosol Tubing with ear wrap cushions
SALTER LABS
1111TLC
In Commercial Distribution

  • 10607411804981 ()
  • 00607411804984 ()

  • Adult
1111TLC

  • Aerosol face mask, non-rebreathing
10ft with Male Luer and Filter with Microstream Type Luer Connector
FLEXICARE MEDICAL LIMITED
010-712U
In Commercial Distribution

  • 05055788782032 ()


  • Gas-sampling/monitoring respiratory tubing, single-use
7ft O2 Delivery / CO2 Monitoring with Filter with Microstream Type Luer
FLEXICARE MEDICAL LIMITED
032-12-182U
In Commercial Distribution

  • 05055788781752 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
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