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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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Nucleus - 09321502023368

Cochlear Nucleus CP900 Series LiteWear Cable (50 cm, Maize)
COCHLEAR LIMITED
Z285955
In Commercial Distribution

  • 09321502023368 ()

  • Length: 50 Centimeter
  • 50 cm long cable
Z285955

  • Cochlear implant system
  • Cochlear implant/auditory brainstem implant peripheral connector

Nucleus - 09321502019859

Cochlear Nucleus CP800 Series Litewear Cable (50cm, White)
COCHLEAR LIMITED
Z246024
In Commercial Distribution

  • 09321502019859 ()

  • 30 cm long cable
  • Length: 50 Centimeter
Z246024

  • Cochlear implant system
  • Cochlear implant/auditory brainstem implant peripheral connector

Nucleus - 09321502017787

Cochlear Nucleus CP800 Series Compact Rechargeable Battery Module (White)
COCHLEAR LIMITED
Z202222
In Commercial Distribution

  • 09321502017787 ()
Z202222

  • Portable/mobile rechargeable battery pack
  • Cochlear implant/auditory brainstem implant battery

OMNI™ II - 00810003380012

OMNI™ II Programmer System (with OMNI Smart Software). System consists of: (1) OMNI II Programmer (with OMNI Smart Software) (1) OMNI II Programmer Tablet PC installed with OMNI Smart Programmer Software (1) OMNI II Programmer Interface Box (1) OMNI II Programmer Interface Box Cable (1) Medical-grade Ethernet isolator with Ethernet patch cable (1) OMNI II Programmer Wand (1) OMNI II Programmer Wand Extension Cable (1) USB to Serial Adapter Assembly (1) Single-lead (3-wire) ECG cable (1) Medical-grade Power Supply (1) Medical-grade Power Cord (1) Bluetooth printer with AC Adapter (2) Bluetooth printer paper rolls
Impulse Dynamics (usa) Inc.
Programmer System (with OMNI Smart Software)
In Commercial Distribution

  • 00810003380012 ()
10-A604-3-US

  • Cardiac contractility modulation system programmer

3100B HFOV - 10190752158825

3100B Disposable Items Kit / F&P 850
VYAIRE MEDICAL, INC.
775855
In Commercial Distribution

  • 10190752158825 ()
775855

  • Respiratory gas heating wire, adult
  • Microbial medical gas filter, single-use
  • Breathing circuit condensate trap, single-use
  • Carpal lunate prosthesis

3100B HFOV - 10190752158818

3100B Disposable Items Kit / F&P 730
VYAIRE MEDICAL, INC.
775854
In Commercial Distribution

  • 10190752158818 ()
775854

  • Breathing circuit condensate trap, single-use
  • Respiratory gas heating wire, adult
  • Carpal lunate prosthesis
  • Microbial medical gas filter, single-use

3100B HFOV - 10190752158801

3100B Disposable Items Kit / HRCI
VYAIRE MEDICAL, INC.
775853
In Commercial Distribution

  • 10190752158801 ()
775853

  • Respiratory gas heating wire, adult
  • Carpal lunate prosthesis
  • Microbial medical gas filter, single-use
  • Breathing circuit condensate trap, single-use

3100A HFOV - 10190752155411

3100A DISPOSABLES SHIP KIT (MR850 FLEX CIRCUIT)
VYAIRE MEDICAL, INC.
770630-103
Not in Commercial Distribution

  • 10190752155411 ()
770630-103

  • Breathing circuit condensate trap, single-use
  • Respiratory gas heating wire, adult
  • Microbial medical gas filter, single-use
  • Ventilator breathing circuit, single-use

3100A HFOV - 10190752155404

3100A DISPOSABLES SHIP KIT (MR730 FLEX CIRCUIT)
VYAIRE MEDICAL, INC.
770630-102
Not in Commercial Distribution

  • 10190752155404 ()
770630-102

  • Ventilator breathing circuit, single-use
  • Respiratory gas heating wire, adult
  • Microbial medical gas filter, single-use
  • Breathing circuit condensate trap, single-use

3100A HFOV - 10190752200760

3100A DISPOSABLES SHIP KIT (MR730 FLEX CIRCUIT)
VYAIRE MEDICAL, INC.
770630-102
In Commercial Distribution

  • 10190752200760 ()
770630-102

  • Ventilator breathing circuit, single-use
  • Respiratory gas heating wire, adult
  • Microbial medical gas filter, single-use
  • Breathing circuit condensate trap, single-use
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