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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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Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 103-09N-O
Not in Commercial Distribution

  • 04035324013340 ()

  • Lumen/Inner Diameter: 7.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 103-08N-O
Not in Commercial Distribution

  • 04035324013302 ()

  • Lumen/Inner Diameter: 6.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Standard Grasper with Spoon, rotatable 1-piece with flush port, type 1 handle
Avalign Technologies, Inc.
72-5223602B1
In Commercial Distribution

  • 00190776350857 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
AF541 Under the Nose Mask, with Standard Elbow, with Capstrap, SIZE B
Respironics, Inc.
AF541 Mask, SE, Under Nose, w/Capstrap, SIZE B
In Commercial Distribution

  • 30606959046697 ()
  • 00606959046696 ()
1133718

  • CPAP/BPAP face mask, single-use
AF541 Under the Nose Mask with Standard Elbow, with Capstrap, SIZE A
Respironics, Inc.
AF541 Mask, SE, Under Nose, w/Capstrap, SIZE A
In Commercial Distribution

  • 30606959046680 ()
  • 00606959046689 ()
1133717

  • CPAP/BPAP face mask, single-use
DreamWisp Nasal Mask, Extra Large with Small Medium Connector, with Headgear, Korea
Respironics, Inc.
DreamWisp Mask, XL, Sm/Med Connector, W/Headgear, KR
Not in Commercial Distribution

  • 00606959054493 ()
1139336

  • CPAP/BPAP nasal mask, reusable
Catheter with Outer Stiffener with Stainless Steel Core, 10cm, model number Type5-v4
KITAZATO CORPORATION
131106 Type5-v4
In Commercial Distribution

  • 14580303269265 ()
  • 04580303269268 ()
131106

  • Assisted reproduction transfer catheter/set
Catheter with Outer Stiffener with Stainless Steel Core, 10cm, model number Type5-v3
KITAZATO CORPORATION
131101 Type5-v3
In Commercial Distribution

  • 14580303269258 ()
  • 04580303269251 ()
131101

  • Assisted reproduction transfer catheter/set
Catheter with Outer Stiffener with Stainless Steel Core, 18cm, model number Type5-v2
KITAZATO CORPORATION
131186 Type5-v2
In Commercial Distribution

  • 14580303269241 ()
  • 04580303269244 ()
131186

  • Assisted reproduction transfer catheter/set
Catheter with Outer Stiffener with Stainless Steel Core, 18cm, model number Type5-v1
KITAZATO CORPORATION
131181 Type5-v1
In Commercial Distribution

  • 14580303269234 ()
  • 04580303269237 ()
131181

  • Assisted reproduction transfer catheter/set
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