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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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Cardiac Monitor - 00862887000357

Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM500
Not in Commercial Distribution

  • 00862887000357 ()


  • Electrocardiographic ambulatory recorder

CardioPAL SAVI - 00862887000340

CardioPAL SAVI is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM410
Not in Commercial Distribution

  • 00862887000340 ()


  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094212464

TAGCONNECT SOFTWARE AND SMART CABLE
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094212464 ()
TAGECG-SW

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094257786

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); AHA 5 wire, 27 in. (69cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094257786 ()
H3PLUS-CAA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094246896

TAGECG WEARABLE SENSOR
WELCH ALLYN, INC.
901098
In Commercial Distribution

  • 00732094212471 ()
  • 00732094246896 ()
TAGECG-1

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094309300

Reconditioned H12+ 12-lead digital Holter Recorder - 24-hour with HF (high fidelity) for 24-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094309300 ()
H12PLUS-JPA-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094309294

Reconditioned H12+ 12-lead digital Holter Recorder - 24-hour with HF (high fidelity) for 24-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 10-wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094309294 ()
H12PLUS-JPB-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094309287

Reconditioned H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094309287 ()
H12PLUS-KPA-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094309270

Reconditioned H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 10-wire, 12- lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094309270 ()
H12PLUS-KPB-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094294118

H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-hour high-fidelity recordings, includes HF compact flash card (1 GB), carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 38"" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094294118 ()
H12PLUS-HPA-XXXXX

  • Electrocardiographic ambulatory recorder
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