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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™ 1308 Ultra Compact 12- Channel ECG Holter Recorder - 00817980020030

12 CH ECG Holter Ultra Recorder
VASOMEDICAL, INC.
Model 1308
In Commercial Distribution

  • 00817980020030 ()
A10-1308-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1304 12 Channel ECG Holter Recorder - 00817980020023

12 CH ECG Holter Recorder
VASOMEDICAL, INC.
Model 1304
In Commercial Distribution

  • 00817980020023 ()
A10-0082

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1307 Ultra Compact 3 Channel ECG Holter Recorder - 00817980020016

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

  • 00817980020016 ()
A10-1307-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 1305 3 Channel ECG Holter Recorder - 00817980020009

3 CH ECG Holter Recorder
VASOMEDICAL, INC.
Model 1305
In Commercial Distribution

  • 00817980020009 ()
A10-0083

  • Electrocardiographic ambulatory recorder

H3+ - 00812345027112

Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-BAD-XXXXX
In Commercial Distribution

  • 00812345027112 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00812345027105

Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-BAA-XXXXX
In Commercial Distribution

  • 00812345027105 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345027099

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

  • 00812345027099 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00812345027044

Holter Recorder
MORTARA INSTRUMENT, INC.
BURH3PR
In Commercial Distribution

  • 00812345027044 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00812345021684

Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-AAA-XXXXX
In Commercial Distribution

  • 00812345021684 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00812345021660

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

  • 00812345021660 ()


  • Electrocardiographic ambulatory recorder
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