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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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OPUS 2 FM Extension Kit ebony - 09008737074388

Audio Processor Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
07438
In Commercial Distribution

  • 09008737074388 ()


  • Cochlear implant/auditory brainstem implant battery

OPUS 2 FM Extension Kit white - 09008737074371

Audio Processor Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
07437
In Commercial Distribution

  • 09008737074371 ()


  • Cochlear implant/auditory brainstem implant battery

OPUS 2 Children's Extension Kit blue - 09008737050122

Audio Processor Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
05012
In Commercial Distribution

  • 09008737050122 ()


  • Cochlear implant/auditory brainstem implant battery

OPUS 2 FM Extension Kit red - 09008737050078

Audio Processor Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
05007
In Commercial Distribution

  • 09008737050078 ()


  • Cochlear implant/auditory brainstem implant battery

t:slim X2 Cartridge, t:lock, 2 Pack - 00853052007233

t:slim G4 / X2 Cartridge, t:lock, 2 Pack
Tandem Diabetes Care, Inc.
1000728
In Commercial Distribution

  • 00853052007233 ()
  • 00853052007547 ()

  • Total Volume: 3 Milliliter


  • Ambulatory insulin infusion pump reservoir

System Destination Kit, CE 2 EPG - 00852184003069

No Description
Synapse Biomedical, Inc.
20-0063
In Commercial Distribution

  • 00852184003069 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

2 Pack, Electrode Delivery Tool Kit - 00852184003618

No Description
Synapse Biomedical, Inc.
20-0074
In Commercial Distribution

  • 00852184003618 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

LungFit PH Breathing Circuit 2 Kit - B882800120

Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line.
Beyond Air, Inc.
80012
In Commercial Distribution

  • B882800120 ()


  • Nitric oxide delivery unit, system-based

CHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes - 00883873824603

SHIPPING ASSY-C-P, Q-P,REPL KIT, 2 ELECTRODE
PHYSIO-CONTROL, INC.
11403
In Commercial Distribution

  • 00883873824603 ()
11403-000001

  • External defibrillation electrode, adult, single-use

Tridyne - 10801741099370

Tridyne, Vascular Sealant, 2 Applicator Spray Tips
NEOMEND, INC.
TDST0020
In Commercial Distribution

  • 20801741099377 ()
  • 10801741099370 ()
  • 00801741099373 ()
TDST0020

  • General-purpose absorbent tip applicator/swab, single-use
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