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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 - 00606959012240

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 - 00606959011618

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 - 00606959011601

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 - 00606959046146

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 - 00606959046108

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 - 00606959046061

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

N/A - 00607411940675

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

N/A - 00607411804984

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

Monitoring Line - 05055788782032

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

Dual Pediatric Nasal Cannula - 05055788781752

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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