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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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H12+ Standard 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); IEC 10-wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328868 ()
H12PLUS-LPB-XXXXX

  • Electrocardiographic ambulatory recorder
H12+ Standard 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); IEC 10-wire, 12-lead LeadForm 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328844 ()
H12PLUS-LPD-XXXXX

  • Electrocardiographic ambulatory recorder
H12+ Standard 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); IEC 10-wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328837 ()
H12PLUS-MPB-XXXXX

  • Electrocardiographic ambulatory recorder
H12+ Standard 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); IEC 10-wire, 12-lead LeadForm 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328813 ()
H12PLUS-MPD-XXXXX

  • Electrocardiographic ambulatory recorder
Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; Custom display and control (Project Management required); 110V HP LaserJet network printer; Dual color LCD 24" monitors with high resolution and dual stand
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094318920 ()
SCAC-AAA-EADXX

  • Centralized patient monitor
Welch Allyn Harvey DLX Cardiology Stethoscope with Stainless Steel Triple-Head Chestpiece (Low-Frequency Bell, Adult Diaphragm, and Pediatric Diaphragm), Dual Lumen Latex-Free Tubing, Harvey Heart Sounds CD, Harvey DLX Accessory Kit (#5079-315); 28 in/71.1 cm; Navy
WELCH ALLYN, INC.
901039
In Commercial Distribution

  • 00732094115031 ()
5079-323S

  • Mechanical external stethoscope
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No 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

  • 00732094263022 ()
RSCRIBE-6EC-XXDBX

  • Electrocardiograph, professional, multichannel
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU, no display; UK power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with 43" leadwires with pinch for AM12Q; Isolation transformer 1000
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094338720 ()
QS-6AB-CEAAB

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; No power cord; No printer, Q-Stress basic laser transport cart with keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 int
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094338515 ()
QS-6ID-XGDAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output and RScribe with Interpretation; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; No power cord; No printer, basic laser transport cart with base and back panel; AHA 10 wire, 12-lead lead set with medi-clips; Isolation trans
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094338508 ()
XSCRIBE-6EA-XEAAA

  • Cardiopulmonary stress exercise monitoring system computer
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