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

  • 00732094264159 ()
H3PLUS-CME-XXXXX

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

  • 00732094264142 ()
H3PLUS-COB-XXXXX

  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); English language, no manual; IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00732094264135 ()
H3PLUS-CZE-XXXXX

  • Electrocardiographic ambulatory recorder
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-032908-00
In Commercial Distribution

  • 06944904086415 ()


  • Patient monitoring system module, printing
Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC5007
In Commercial Distribution

  • 06945040101499 ()


  • Electrocardiographic ambulatory recorder
Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC6000
In Commercial Distribution

  • 06945040101406 ()


  • Electrocardiographic ambulatory recorder
Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC5000
In Commercial Distribution

  • 06945040100294 ()


  • Electrocardiographic ambulatory recorder
PAPER ROLLS, 100MM WIDE,ECG
PHYSIO-CONTROL, INC.
11240
Not in Commercial Distribution

  • 00681490597722 ()
11240-000016

  • Patient monitoring system module, printing
PAPER-ELECTROCARDIOGRAM,RECORDING
PHYSIO-CONTROL, INC.
11240
In Commercial Distribution

  • 00681490595896 ()
11240-000013

  • Patient monitoring system module, printing
Messenger 5.18 Software Release
SPOK INC.
5.18.0
In Commercial Distribution

  • 00865190000304 ()


  • Alarm application software
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