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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. - 00732094263046

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; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263046 ()
RSCRIBE-6EC-XXDBB

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094262940

RScribe 12-Lead Multi-Channel Electrocardiograph - version 7, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); IEC 10 wire, 12-lead lead set with banana plugs; No connectivity
WELCH ALLYN, INC.
901127
Not in Commercial Distribution

  • 00732094262940 ()
RSCRIBE-7CC-XXABX

  • Electrocardiograph, professional, multichannel

BPMS Evolution - B970BCE5315535010

Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5350, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (1) 5315 Sensor with Sensor Cover and (1) 5350 Sensor with Sensor Cover, and 1 Web-Based Training Session (USA Only)
Tekscan, Inc.
BPMS 1 System (5315-5350 Sensors)
In Commercial Distribution

  • B970BCE5315535010 ()
BCE5315-5350-1

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00732094321692

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity- includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094321692 ()
RSCRIBE-6CC-XXDAA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094309300

Reconditioned H12+ 12-lead digital Holter Recorder - 24-hour with HF (high fidelity) for 24-hour high-fidelity recordings, includes HF compact flash card (1 GB), 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

  • 00732094309300 ()
H12PLUS-JPA-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094309287

Reconditioned H12+ 12-lead digital Holter Recorder - 48-hour with HF (high fidelity) for 30-hour high-fidelity recordings, includes HF compact flash card (1 GB), 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

  • 00732094309287 ()
H12PLUS-KPA-XXXXR

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094283419

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity- includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094283419 ()
RSCRIBE-6AC-XXDAA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094334944

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; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094334944 ()
RSCRIBE-6CC-AXDBA

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094263121

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Non-interpretive; Software kit; Australia power cord; No printer; Suction electrodes (6) and clamps (4); IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263121 ()
RSCRIBE-6BC-BXCBA

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094263107

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; Advanced connectivity-includes DICOM order and output and XML order and XML/PDF output
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263107 ()
RSCRIBE-6CC-AXDBB

  • Electrocardiograph, professional, multichannel
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