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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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Vasomedical-Biox™ Model 2301 3 CH/ABP COMB Recorder - 5 Lead Patient Cable - 00817980020498

Model 2301 3 CH/ABP COMB Recorder - 5 Lead Patient Cable
VASOMEDICAL, INC.
Model 2301 Kit
In Commercial Distribution

  • 00817980020498 ()
A10-2301-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1307 3 CH ULTRA Recorder - 00817980020443

Model 1307 3 CH ULTRA Recorder
VASOMEDICAL, INC.
Model 1307 Kit
In Commercial Distribution

  • 00817980020443 ()
A10-1307-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1305 3 CH Recorder - 7 Lead Patient Cable - 00817980020429

Model 1305 3 CH Recorder - 7 Lead Patient Cable
VASOMEDICAL, INC.
Model 1305 Kit
In Commercial Distribution

  • 00817980020429 ()
A10-1305-01-04-03

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1305 3 CH Recorder - 5 Lead Patient Cable - 00817980020412

Model 1305 3 CH Recorder - 5 Lead Patient Cable
VASOMEDICAL, INC.
Model 1305 Kit
In Commercial Distribution

  • 00817980020412 ()
A10-1305-01-04-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1303 3 CH ULTRA Recorder w/LCD - 5 Lead Patient Cable - 00817980020399

Model 1303 3 CH ULTRA Recorder w/LCD - 5 Lead Patient Cable
VASOMEDICAL, INC.
Model 1303 Kit
In Commercial Distribution

  • 00817980020399 ()
A10-1303-01-04-02

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1201 3 CH Mini ECG Recorder - 00817980020375

Model 1201 3 CH Mini ECG Recorder
VASOMEDICAL, INC.
Model 1201 Kit
In Commercial Distribution

  • 00817980020375 ()
A10-1201-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ Model 1200 2 CH Mini ECG Recorder - 00817980020368

Model 1200 2 CH Mini ECG Recorder
VASOMEDICAL, INC.
Model 1200 Kit
In Commercial Distribution

  • 00817980020368 ()
A10-1200-00

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1200 ECG Holter Mini Recorder - 00817980020344

1200 ECG Holter Mini Recorder
VASOMEDICAL, INC.
Model 1200
In Commercial Distribution

  • 00817980020344 ()
A10-1200-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder - 00817980020184

12 CH ECG Holter ULTRA Recorder
VASOMEDICAL, INC.
Model 1306
In Commercial Distribution

  • 00817980020184 ()
A10-1306-01

  • Electrocardiographic ambulatory recorder

H12+ - 00817655022932

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-BHB-XXXXX
Not in Commercial Distribution

  • 00817655022932 ()


  • Electrocardiographic ambulatory recorder
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