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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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DreamWear Under the Nose Nasal Mask, Medium, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, M, S Frame with Headgear, Global
In Commercial Distribution

  • 00606959030824 ()
1116686

  • CPAP/BPAP nasal mask, reusable
DreamWear Under the Nose Nasal Mask, Small, with Small Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, S, S Frame w/Headgr, Global
In Commercial Distribution

  • 00606959030787 ()
1116685

  • CPAP/BPAP nasal mask, reusable
DreamWear Under the Nose Nasal Mask, Large, with Medium Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, L, M Frame w/Headgr, Global
In Commercial Distribution

  • 00606959030718 ()
1116682

  • CPAP/BPAP nasal mask, reusable
AMARA GEL MASK WITH STANDARD ELBOW, WITH RS FRAME AND HEADGEAR, LARGE, JAPAN
Respironics, Inc.
AMARA GEL MASK w/SE, with RS FRAME, Headgear, Large, JP
Not in Commercial Distribution

  • 00606959025332 ()
1090456

  • CPAP/BPAP face mask, reusable
AMARA GEL MASK WITH STANDARD ELBOW WITH RS FRAME AND HEADGEAR JPN, SMALL
Respironics, Inc.
AMARA GEL MASK w/SE, with RS FRAME, Headgear, Small, JP
Not in Commercial Distribution

  • 00606959025318 ()
1090451

  • CPAP/BPAP face mask, reusable
AF531 Mask with Entrainment Elbow (Nebulizing Elbow), with Four Point Headgear, Small, USA
Respironics, Inc.
AF531 Mask EE (NE) with 4 point Headgear, Small, USA
In Commercial Distribution

  • 30606959012340 ()
  • 00606959012349 ()
1094811

  • CPAP/BPAP face mask, single-use
DreamWear Under the Nose Nasal Mask, Medium, with Medium Frame, with Headgear, Global
Respironics, Inc.
DreamWear Under Nose Mask, M, M Frame w/Headgr, Global
In Commercial Distribution

  • 00606959030688 ()
1116681

  • CPAP/BPAP nasal mask, reusable
Bitestrong Bite Blocks with Nasal Oxygen Delivery, 18 mm, single use, with stap
Batrik Medical Manufacturing Inc
BO2
In Commercial Distribution

  • 00690521000100 ()
BO2

  • Endoscopic bite block, basic, single-use
Sentrus Insufflation Tubing with CO2 Connector, Insufflation tubing with CO2 connection hose (Olympus)
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-EFC-O-D1-B1
In Commercial Distribution

  • 16936603231163 ()
  • 06936603231166 ()
SEN-INT-O-CO2

  • Endoscopic insufflation tubing set, single-use
microTargeting Insertion Tube with Stylet, nonsterile, at target, for use with Nexframe/Nexdrive
FHC, INC.
66-IT(DB12)-00521
In Commercial Distribution

  • 00873263005217 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
  • Length: 211.6 Millimeter
66-IT(DB12)

  • Intracerebral cannula, implantable
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