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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 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; Burgundy
WELCH ALLYN, INC.
901039
In Commercial Distribution

  • 00732094115086 ()
5079-322S

  • Mechanical external stethoscope
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
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS, Multi User License (up to 10 User) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-A2
In Commercial Distribution

  • 07290110255428 ()
HASP-SW-K-NEMS-A-02

  • Patient-administration information system application software
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis, including support for NR via USB The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-2
In Commercial Distribution

  • 07290110254971 ()
HASP-SW-K-NH301-4-02

  • Electrocardiographic long-term ambulatory recording analyser
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
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
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
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