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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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Bittium Faros - 06430035220366

Device for 3-channel ECG and motion measurement, monitoring and data collection
Bittium Biosignals Oy
Faros 14d
In Commercial Distribution

  • 06430035220366 ()


  • Telemetric electrocardiographic ambulatory recorder

Bittium Faros 180 waterproof - 06430035220328

Device for 1-channel ECG and motion measurement, monitoring and data collection
Bittium Biosignals Oy
Faros 180
In Commercial Distribution

  • 06430035220328 ()


  • Telemetric electrocardiographic ambulatory recorder

Faros 360 waterproof - 06430035220311

Device for 3-channel ECG and motion measurement, monitoring and data collection.
Bittium Biosignals Oy
Faros 360
In Commercial Distribution

  • 06430035220311 ()
901159

  • Telemetric electrocardiographic ambulatory recorder

IntelliBridge - 00884838090811

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

  • 00884838090811 ()
865056

  • Medical networking interface unit

Volk Pictor Prestige full set - 06430046260870

Volk Pictor Prestige full set including Pictor Prestige camera, Pictor Prestige Retina module and Pictor Prestige Anterior module.
Optomed Oy
60101810A
In Commercial Distribution

  • 06430046260870 ()


  • Multi-purpose digital medical camera

Optomed Aurora retinal set - 06430046260795

Optomed Aurora retinal set including Aurora camera and Aurora retinal module.
Optomed Oy
60101078A
In Commercial Distribution

  • 06430046260795 ()


  • Multi-purpose digital medical camera

Pictor M5WEY4 Volk FN - 06430046260672

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

  • 06430046260672 ()


  • Multi-purpose digital medical camera

BodyGuardian Kit - 00852132007491

BodyGuardian Mini Plus SL CEM Lite Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-66
In Commercial Distribution

  • 00852132007491 ()


  • Medical networking interface unit

BodyGuardian Kit - 00852132007453

BodyGuardian Mini Plus EL CEM Lite Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-67
In Commercial Distribution

  • 00852132007453 ()


  • Medical networking interface unit

BodyGuardian Kit - 00852132007446

BodyGuardian One 4G VZW Kit - Arden Hills
PREVENTICE TECHNOLOGIES, INC.
L-46
In Commercial Distribution



  • Medical networking interface unit
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