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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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Lumicell Direct Visualization System (DVS) - 00860003252536

Light source
Lumicell, Inc.
810-00212
In Commercial Distribution

  • 00860003252598 ()
  • 00860003252536 ()


  • Intraoperative tumour margin fluorescence imaging system

Canary Home Base Station - 00860003118320

The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Canary Medical USA LLC
43-5570-001-14
In Commercial Distribution

  • 00860003118320 ()


  • Medical networking interface unit

CONTEC - 06945040104421

Portable ECG Monitor
Contec Medical Systems Co., Ltd.
PM10
In Commercial Distribution

  • 06945040104421 ()


  • Telemetric electrocardiographic ambulatory recorder

CONTEC - 06945040101505

Portable ECG Monitor
Contec Medical Systems Co., Ltd.
PM10
In Commercial Distribution

  • 06945040101505 ()


  • 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

Saver EVO - M727SAVEREVOH013

Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution

  • M727SAVEREVOH013 ()
PAD-ACC-03

  • External defibrillator application software

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

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
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