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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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Salter Air Elite® with NebuTech® HDN®, with Nebulizer
SALTER LABS
8352-8660-7-1
In Commercial Distribution

  • 00607411001536 ()
8352-8660-7-1

  • Benchtop nebulizer, non-heated
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
Aveta Waste Bag with Tissue Catch for use with Aveta System
MEDITRINA, INC.
205-2037
In Commercial Distribution

  • 10850006759733 ()
  • 00850006759736 ()
205-2037

  • Surgical tissue/fluid collection bag
Aveta Tissue Catch with Suction Tubing for use with Aveta System
MEDITRINA, INC.
205-116
In Commercial Distribution

  • 00850006759200 ()
  • 00850006759101 ()
205-116

  • Tissue morcellation system tissue preservation container
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
10ft O2 Delivery/CO2 Monitoring with Filter with Microstream Type Luer
FLEXICARE MEDICAL LIMITED
032-12-183U
In Commercial Distribution

  • 05055788781738 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
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
Unassembled Digital Platform Scale with Handrails and Height Rod with BT
Pelstar, LLC
3001KL-AMUA-BT
In Commercial Distribution

  • 00851628008486 ()


  • Stand-on floor scale, electronic
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