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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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Pictor M5WEY4 Volk FN - 06430046260672

Volk Pictor Plus retinal set
Optomed Oy
60100077A
In Commercial Distribution

  • 06430046260672 ()


  • Multi-purpose digital medical camera

Pictor M5WEY4ES2 Volk FN - 06430046260658

Volk Pictor Plus full set
Optomed Oy
60100075A
In Commercial Distribution

  • 06430046260658 ()


  • Multi-purpose digital medical camera

Volk Pictor Prestige retinal set - 06430046260887

Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Prestige retina module.
Optomed Oy
60101813A
In Commercial Distribution

  • 06430046260887 ()


  • Multi-purpose digital medical camera

Optomed Aurora full set - 06430046260757

Aurora full set including Aurora camera, Aurora Retinal module and Aurora Anterior module.
Optomed Oy
60100635A
In Commercial Distribution

  • 06430046260757 ()


  • Multi-purpose digital medical camera

IntelliBridge - 00884838090811

IntelliBridge EC40/80
Philips Medical Systems Hsg
IntelliBridge EC40/80
Not in Commercial Distribution

  • 00884838090811 ()
865056

  • Medical networking interface unit

GD - 00862186000386

The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators over radio/phone communications systems.
General Devices
Rosetta-Lt Data Translator
Not in Commercial Distribution

  • 00862186000386 ()
040-184-7100

  • Medical networking interface unit

GD - 00862186000379

The CAREpoint Workstation (Version 1 and 2) communication console is a standard radio/telephony communications console used for vice and data communications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e. 2 way radio, landline, wireless telephone) as which are commonly used for commercial and public safety (i.e. police, fire, EMS) communication purposes.
General Devices
CAREpoint Workstation
Not in Commercial Distribution

  • 00862186000379 ()
040-183-4000

  • Medical networking interface unit

Polytel - 00861700000376

Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bluetooth 2.1 connectivity for telehealth applications. This is built on a PWR-09-02 device, which an also support other glucose meter families if appropriate cables are provided: "B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ, "A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite
Polymap Wireless
GMA2-L
In Commercial Distribution

  • 00861700000376 ()


  • Medical networking interface unit

Polytel - 00861700000369

Cable to connect Polytel PWR-09-02 GMA2 to Bayer family glucose meters
Polymap Wireless
"B" cable for GMA2
In Commercial Distribution

  • 00861700000369 ()
RYPLX03

  • Medical networking interface unit

Polytel - 00861700000352

Cable to be used with Polytel PWR-09-02 GMA2 to support Abbott glucose meters
Polymap Wireless
"A" cable for GMA2
In Commercial Distribution

  • 00861700000352 ()
RPLYX02

  • Medical networking interface unit
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