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
DreamWisp Nasal, Petite with Medium Connector with Headgear, Central Eastern Europe
Respironics, Inc.
DreamWisp Mask, Petite, Med Connector w/Headgear, CEE
In Commercial Distribution

  • 00606959057289 ()
1137942CE

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Small with Small Medium Connector with Headgear, Korea
Respironics, Inc.
DREAMWISP Mask, Small, Sm/Med Connector W/Headgear, KR
Not in Commercial Distribution

  • 00606959054462 ()
1139333

  • CPAP/BPAP nasal mask, reusable
AF531 Mask with Entrainment Elbow, with 4 Point Headgear, Medium, USA
Respironics, Inc.
AF531 Mask EE with 4 point Headgear, Medium, USA
In Commercial Distribution

  • 30606959012234 ()
  • 00606959012233 ()
1094800

  • CPAP/BPAP face mask, single-use
DreamStation Auto CPAP with Humidifier, with Heated Tube, and WiFi, Domestic
Respironics, Inc.
DreamStation Auto CPAP w/Humid w/H Tube w/WiFi, US
In Commercial Distribution

  • 00606959034129 ()
DSX500T11W

  • Home CPAP unit
DreamWear Gel Pillows Mask, Large, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, Large, L Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026971 ()
1125023

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Small, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, S, Large Frame w/Hgr, Global
In Commercial Distribution

  • 00606959026957 ()
1125021

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Small, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, S, Small Frame w/Hgr, Global
In Commercial Distribution

  • 00606959026926 ()
1125018

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Medium, with Medium Frame with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, M, Med Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026902 ()
1125016

  • CPAP/BPAP nasal mask, reusable
AF541 Mask with Entrainment Elbow, Leak 2, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, X-LARGE
In Commercial Distribution

  • 30606959024596 ()
  • 00606959024595 ()
1121073

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 2, with Four-Point Headgear, Small
Respironics, Inc.
AF541 Mask EE, Leak 2 with 4 Point Headgear, Small
In Commercial Distribution

  • 30606959024527 ()
  • 00606959024526 ()
1121066

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask EE, Leak 1, with Capstrap, XLarge, US
In Commercial Distribution

  • 30606959024435 ()
  • 00606959024434 ()
1121065

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with Four-Point Headgear, Large
Respironics, Inc.
AF541 Mask EE, Leak 1, w/ 4 Point Headgear, Large
In Commercial Distribution

  • 30606959024381 ()
  • 00606959024380 ()
1121060

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with Four-Point Headgear, Medium
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ 4 Point Headgear,Medium
In Commercial Distribution

  • 30606959024374 ()
  • 00606959024373 ()
1121059

  • CPAP/BPAP face mask, single-use
ComfortGel Blue Nasal Mask with Standard Elbow, with Headgear, Small, International
Respironics, Inc.
ComfortGel Blue Nasal Mask w/SE, w/Headgr, Small, INTL
In Commercial Distribution

  • 00606959020825 ()
1070070

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

  • 00606959020818 ()
1070068

  • CPAP/BPAP nasal mask, reusable
AF531 Mask with Entrainment Elbow (Nebulizing Elbow) with CapStrap, USA, Large
Respironics, Inc.
AF531 Mask EE (Nebulizing Elbow) with CapStrap, Large, USA
Not in Commercial Distribution

  • 30606959012395 ()
  • 00606959012394 ()
1094816

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, with 4 Point Headgear, Medium, USA
Respironics, Inc.
AF531 Mask w/SE, with 4 PT Headgear, Medium, USA
Not in Commercial Distribution

  • 30606959012326 ()
  • 00606959012325 ()
1094809

  • CPAP/BPAP face mask, single-use
DreamWear Gel Pillows Mask, Medium, with Large Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, M, L Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026964 ()
1125022

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Large, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, L , Sm Frame w/Headgr, Global
In Commercial Distribution

  • 00606959026940 ()
1125020

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Large, with Medium Frame with Headgear, Global
Respironics, Inc.
DreamWear Gel Pillows Mask, L, Med Frame w/ Headgr, Global
In Commercial Distribution

  • 00606959026919 ()
1125017

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillows Mask, Small, with Medium Frame, with Headgear, Global ,
Respironics, Inc.
DreamWear Gel Pillows Mask, S, Medium Frame w/Hgr, Global
In Commercial Distribution

  • 00606959026896 ()
1125015

  • CPAP/BPAP nasal mask, reusable
AF541 Mask with Entrainment Elbow, Leak 2, with Four-Point Headgear, Medium
Respironics, Inc.
AF541 Mask EE, Leak 2 with 4-Point Headgear, Medium
In Commercial Distribution

  • 30606959024534 ()
  • 00606959024533 ()
1121067

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask EE, Leak 1, with Capstrap, X-Large
In Commercial Distribution

  • 30606959024510 ()
  • 00606959024519 ()
1121495

  • CPAP/BPAP face mask, single-use
Wisp Pediatric Mask Fit Pack with Headgear, with Entrainment Elbow, USA
Respironics, Inc.
Wisp Pediatric Fitpack with Headgear, EE, US
In Commercial Distribution

  • 00606959024236 ()
1104953

  • CPAP/BPAP nasal mask, reusable
REMstar SE with Heated Humidifier, Standard Tube, with SD Slot, Canada
Respironics, Inc.
REMstar SE w/HTD Humid, St Tube, with SD Slot, CA
In Commercial Distribution

  • 00606959020092 ()
CA221NTS

  • Home CPAP unit
  • Heated respiratory humidifier
AF531, with Entrainment Elbow (Nebulizing Elbow), with CapStrap HeadGear, Medium, USA
Respironics, Inc.
AF531 Mask EE (NE) with CapStrap, Medium, USA
Not in Commercial Distribution

  • 30606959012388 ()
  • 00606959012387 ()
1094815

  • CPAP/BPAP face mask, single-use
AF531, with Entrainment Elbow (Nebulizing Elbow), with CapStrap HeadGear, Small, USA
Respironics, Inc.
AF531 Mask EE (NE) with CapStrap, Small, USA
In Commercial Distribution

  • 30606959012371 ()
  • 00606959012370 ()
1094814

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, with 4 Point Headgear, Large, USA
Respironics, Inc.
AF531 Mask w/SE, with 4 Point Headgear, Large, USA
In Commercial Distribution

  • 30606959012333 ()
  • 00606959012332 ()
1094810

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, with 4 Point Headgear, Small, USA
Respironics, Inc.
AF531 Mask w/SE, w/4 PT Headgear, Small, USA
In Commercial Distribution

  • 30606959012319 ()
  • 00606959012318 ()
1094808

  • CPAP/BPAP face mask, single-use
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
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
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 Waste Management Accessory (with cap) for use with Aveta System
MEDITRINA, INC.
205-2001
In Commercial Distribution

  • 00850006759392 ()
  • 00850006759385 ()
205-2001

  • Surgical tissue/fluid collection bag, non-sterile
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
Hexagon socket screws with pivots for Herbst TS / I with base
DENTAURUM GmbH & Co.KG
607-121-30
In Commercial Distribution

  • J011607121300 ()
  • J011607121301 ()


  • Orthodontic power arm
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
Stainless Steel Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform.
FHC, INC.
MP-KIT-MD-00415
In Commercial Distribution

  • 00873263004159 ()

  • Length: 20 Millimeter
MP-KIT-MD

  • Neurological stereotactic surgery system
Stainless Steel Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform.
FHC, INC.
MP-KIT-MB-00413
Not in Commercial Distribution

  • 00873263004135 ()

  • Length: 13 Millimeter
MP-KIT-MB

  • Neurological stereotactic surgery system
US Babcock, with spring tension, flexible and atraumatic, 10mm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8515-13-R
In Commercial Distribution

  • 00848657005784 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Speedlock Needle Holder, 5mm, tapered jaw with TC inserts with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8516-00-R
In Commercial Distribution

  • 00848657004732 ()


  • Suturing needle holder, reusable
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