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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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Welch Allyn, Inc. - 00732094308556

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

  • 00732094308556 ()
H3PLUS-COE-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094296358

TAGECG SMART CABLE
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094296358 ()
TAGECG-SMCABLE

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094296334

TAGconnect Software
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094296334 ()
TAGECG-SWF

  • 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

Welch Allyn, Inc. - 00732094282498

2 channel patient cable for Vison 5L recorder
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094282498 ()
010-1726-00

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094275841

HOOKUP KIT MONITORING 10E SINGLE
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094275841 ()
9294-009-50

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094275834

Holter Hook Up Kit with Prep Items, Patient Diary, 10 electrodes and 1 AA Lithium Battery, Single Kit
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094275834 ()
9294-011-50

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264838

H12+ 12-lead digital Holter Recorder - 48-hour (requires AA Lithium battery), includes standard compact flash card (128 MB), carry case, , and hookup kit; English language and CD manual; IEC 10-wire, 12-lead LeadForm 38 in. (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094264838 ()
H12PLUS-BAB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264388

H3+ 3-channel digital Holter Recorder - 48-hour, includes carry case with clip, and hookup kit (available for US only); 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

  • 00732094264388 ()
H3PLUS-BAE-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094264371

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

  • 00732094264371 ()
H3PLUS-CAB-XXXXX

  • Electrocardiographic ambulatory recorder
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