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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™ 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

Vasomedical-Biox™ 2306 Combined 12 CH ECG Holter & ABP Monitor with Bluetooth - 00817980020122

12 CH ECG Holter/ABP COMB Recorder w/Bluetooth
VASOMEDICAL, INC.
Model 2306
In Commercial Distribution

  • 00817980020122 ()
A10-2306-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 2305 Combined 3 CH ECG Holter & ABP Monitor with Bluetooth - 00817980020115

3 CH ECG Holter/ABP COMB Recorder w/Bluetooth
VASOMEDICAL, INC.
Model 2305
In Commercial Distribution

  • 00817980020115 ()
A10-2305-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 2304 Combined 12 Channel ECG Holter & ABP Monitor - 00817980020108

12 CH ECG Holter/ABP COMB Recorder
VASOMEDICAL, INC.
Model 2304
In Commercial Distribution

  • 00817980020108 ()
A10-2304-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 2303 Combined 3 Channel ECG Holter & ABP Monitor - 00817980020092

3 CH ECG Holter/ABP COMBINED Recorder
VASOMEDICAL, INC.
Model 2303
In Commercial Distribution

  • 00817980020092 ()
A10-2303-01

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 2302 Combined 12 Channel ECG Holter & ABP Monitor - 00817980020085

12 CH ECG Holter/ABP COMBINED Recorder
VASOMEDICAL, INC.
Model 2302
In Commercial Distribution

  • 00817980020085 ()
A10-0086

  • Electrocardiographic ambulatory recorder

Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP Monitor - 00817980020078

3 CH ECG Holter/ABP COMBINED Recorder
VASOMEDICAL, INC.
Model 2301
In Commercial Distribution

  • 00817980020078 ()
A10-0085

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00817655020853

H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Multiple languages and CD manual (except Brazilian Portuguese); IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00817655020853 ()
H3PLUS-CAE-XXXXX

  • Electrocardiographic ambulatory recorder

H12+ - 00817655022086

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

  • 00817655022086 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00817655020440

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

  • 00817655020440 ()


  • Electrocardiographic ambulatory recorder
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