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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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Cook - 00827002576247

Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57624
In Commercial Distribution

  • 00827002576247 ()
C-CAE-8.0-45-01

  • Endotracheal tube guide, single-use

Cook - 00827002576230

Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57623
In Commercial Distribution

  • 00827002576230 ()
C-CAE-19.0-83-01

  • Endotracheal tube guide, single-use

Cook - 00827002576223

Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57622
In Commercial Distribution

  • 00827002576223 ()
C-CAE-14.0-83-01

  • Endotracheal tube guide, single-use

Cook - 00827002576216

Cook Airway Exchange Catheter with Rapi-Fit Adapters
COOK INCORPORATED
G57621
In Commercial Distribution

  • 00827002576216 ()
C-CAE-11.0-83-01

  • Endotracheal tube guide, single-use

Xper Flex Cardio Physiomonitoring System - 00884838093782

Xper Flex Cardio 2020 Rev E Exchange
Philips Ds North America LLC
Xper Flex Cardio 2020 Rev E Exchange
Not in Commercial Distribution

  • 00884838093782 ()
453564845861

  • General-purpose multi-parameter bedside monitor

AMICUS Exchange Kit - Therapeutics - 04086000101950

For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2349
In Commercial Distribution

  • 04086000101950 ()
  • 14086000101957 ()
X6R2349

  • Therapeutic plasma/red blood cell exchange tubing set

InQwire® Amplatz - 00884450239476

No Description
Merit Medical Systems, Inc.
00884450239476
In Commercial Distribution

  • 10884450239473 ()
  • 00884450239476 ()
  • 20884450239470 ()

  • Tip Shape-3 mm J-Tip
  • Length-260 cm (102")
  • Configuration-Amplatz Exchange
  • Length-260 cm (102"); Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
  • Configuration-Amplatz Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
IQA502

  • Cardiac/peripheral vascular guidewire, single-use

BladderScan® - 00879123008015

BladderScan® Prime Plus™ Probe, Probe Exchange
VERATHON INC
Prime Plus™
In Commercial Distribution

  • 10879123008012 ()
  • 00879123008015 ()
E570-0395

  • Bladder ultrasound imaging transducer

Gyrus ACMI - 00821925027114

REPAIR EXCHANGE AUTOCLAVABLE SCOPE 4MM 0 DEGREES WIDE
Gyrus ACMI, LLC
REX70230910
In Commercial Distribution

  • 00821925027114 ()


  • Rigid optical sinoscope

OTOVIEW - 00821925027411

REPAIR EXCHANGE OTOVIEW SCOPE 2.4 MM 0 DEGREE
Gyrus ACMI, LLC
REX23-5210
In Commercial Distribution

  • 00821925027411 ()


  • Otoscope, endoscopic
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