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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. - 00732094263992

HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; No power cord-OUS option only; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263992 ()
HSCRIBE-6AC-XXXXE

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094263985

HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Software kit; Australia power cord; No printer
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263985 ()
HSCRIBWS-6AC-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094263978

HScribe Server - version 6, current software CD; Software kit; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263978 ()
HSERV-6AA-XXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Holter Software - 00884838094895

Philips Holter Software w/ Zymed Alg
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838094895 ()
860292

  • Electrocardiographic long-term ambulatory recording analyser application software

Earlens Wireless Updater - 08500130070000

Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit

HScribe - 00812345029857

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSERV-6AA-XXXXA
In Commercial Distribution

  • 00812345029857 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345029840

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-YXXXC
In Commercial Distribution

  • 00812345029840 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345029826

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBEWS-6AC-YXXXX
In Commercial Distribution

  • 00812345029826 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027334

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-XXXXX
In Commercial Distribution

  • 00812345027334 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00812345027280

Holter Analysis System
MORTARA INSTRUMENT, INC.
HSREV-AAA-BXXAA
Not in Commercial Distribution

  • 00812345027280 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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