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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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Aveta Waste Bag with Tissue Catch - 00850006759736

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 - 00850006759385

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 - 00850006759101

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

N.A. - J011607121300

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

Ethox Medical - 10889483150160

Gastric Lavage Kit with Spike, (2) 25g Activated Charcoal with Sorbitol
ETHOX MEDICAL, LLC
950098203
In Commercial Distribution

  • 20889483150167 ()
  • 10889483150160 ()


  • Gastric lavage kit

Salter AIRE Elite, NebuTech - 00607411001536

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 - 00606959057289

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 - 00606959057272

DreamWisp Nasal, Extra Large with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, XL, Med Connector w/Headgear, AP
In Commercial Distribution

  • 00606959057272 ()
1137946AP

  • CPAP/BPAP nasal mask, reusable

DreamWisp - 00606959054479

DreamWisp Nasal Mask, Medium with Small Medium Connector, with Headgear, Korea
Respironics, Inc.
DreamWisp Mask, Med, Sm/Med CONNECTOR, W/Headgear, KR
Not in Commercial Distribution

  • 00606959054479 ()
1139334

  • CPAP/BPAP nasal mask, reusable

DreamWisp - 00606959054462

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

DreamWisp - 00606959054455

DreamWisp Nasal Mask, Petite with Small Medium Connector, with Headgear, Korea
Respironics, Inc.
DreamWisp Mask, Petite, Sm/Med CONNECTOR, w/Headgear, KR
Not in Commercial Distribution

  • 00606959054455 ()
1139332

  • CPAP/BPAP nasal mask, reusable

AF531 - 00606959012394

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 - 00606959012370

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

DreamWear - 00606959026964

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 - 00606959026940

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 - 00606959026926

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 - 00606959026919

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 - 00606959026902

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

DreamWear - 00606959026896

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 - 00606959024595

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
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