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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. - 00732094328769

H12+ High Fidelity 12-lead digital Holter Recorder - 48-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328769 ()
H12PLUS-OPC-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094327779

H12+ High Fidelity 12-lead digital Holter Recorder - 24-hour, includes secure digital (SD) card, 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

  • 00732094327779 ()
H12PLUS-NPA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094327762

H12+ High Fidelity 12-lead digital Holter Recorder - 48-hour, includes secure digital (SD) card, 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

  • 00732094327762 ()
H12PLUS-OPA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094312829

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; No connectivity
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094312829 ()
RSCRIBE-6CC-AXDBX

  • Electrocardiograph, professional, multichannel

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. - 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. - 00732094319422

XScribe Cardiac Stress – ver 6 w/ adult and ped interp; w/ current sfw CD and User Manual CD; WAM Wireless Acquisition Module w/ Trigger Module for TTL/analog signal output; Turnkey system w/ config CPU and ELO brand capacitive color touchscreen 24" monitor w/ 1920 x 1080 res; UK pwr cord; Z200+ thermal printer(w/ starter pk of full-grid paper), basic transport cart/ base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set w/ medi-clips; Isolation transformer 1000 VA Med Global
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094319422 ()
XSCRIBE-6AB-CDBAA

  • Cardiopulmonary stress exercise monitoring system computer

OPTICAL BIOMETER - 04987669100547

The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method. An optional A-scan probe is also available to scan axial length with an ultrasonic measurement function by touching it to the cornea should optical measurement not be successful. In addition, an anterior eye segment image overlaid with the corneal meridians can be created as a reference for toric IOL implantation. The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.
NIDEK CO.,LTD.
AL-Scan
In Commercial Distribution

  • 04987669100547 ()


  • Optical pachymeter
  • Ophthalmic examination slit lamp
  • Bench-top keratometer
  • Ophthalmic ultrasound imaging system

Norav 1200 Series PC-ECG - 07290110255015

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I3 = Resting-ECG Measurement and Interpretation MEANS (Univ. of Rotterdam, NL) - Network Capability for I3 The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I3-N
In Commercial Distribution

  • 07290110255015 ()
HASP-SW-K-I3-N-02

  • Cardiovascular risk evaluation interpretive software

Norav 1200 Series PC-ECG - 07290110254988

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis - Support for data transfer via USB (for DL900 recorders) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-3
In Commercial Distribution

  • 07290110254988 ()
HASP-SW-K-NH301-4-03

  • Electrocardiographic long-term ambulatory recording analyser
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