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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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Leadwires, 5 Lead Din Style Adult Pinch, AAMI, 24 inch
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094035513 ()
008-0319-00

  • Electrocardiographic lead set, reusable
Lead wires, 3 Lead Din Style Adult Pinch, AAMI, 24 inch
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094035292 ()
008-0321-00

  • Electrocardiographic lead set, reusable
Lead wires, 5 Lead Din Style Snap, AAMI, 24 inch
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094035278 ()
008-0322-00

  • Electrocardiographic lead set, reusable
ECG, 5-Lead Wire Set, safety DIN .060, snap for use with 008-0314-01 (IEC)
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094035261 ()
008-0322-01

  • Electrocardiographic lead set, reusable
Leadwires, 3 Lead Din Style Snap, AAMI, 24 inch
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094035254 ()
008-0323-00

  • Electrocardiographic lead set, reusable
CABLE.ECG 5-LEAD SFTY CONCTOR HP AAMI
WELCH ALLYN, INC.
901006
In Commercial Distribution

  • 00732094035094 ()
008-0330-00

  • Electrocardiographic lead set, reusable
PROPAQ LT CHARGING CRADLE PLUG TYPE G
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094032963 ()
008-0924-00

  • Electrocardiographic lead set, reusable
PROPAQ LT CHARGING CRDLE PLUG TYPE I AU
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094032956 ()
008-0925-00

  • Electrocardiographic lead set, reusable
PRO LT CHRG COMM CRADLE W USB PLUGC EU
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094032949 ()
008-0927-00

  • Electrocardiographic lead set, reusable
PROLT CHRG COMM CRADLE W USB PLUG G UK
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094032932 ()
008-0928-00

  • Electrocardiographic lead set, reusable
PROPAQ LT CHRG.COMM CRADLE W USB PLUG TY
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094032925 ()
008-0929-00

  • Electrocardiographic lead set, reusable
LT LG CLR DPLY IN W CHGCRA USB PLUG I
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094032789 ()
008-0934-00

  • Electrocardiographic lead set, reusable
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; Turnkey system with configured CPU, no display; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global;
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260878 ()
XSCRIBE-6AB-CDBAC

  • Electrocardiographic lead set, reusable
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; Turnkey system with configured CPU, no display; UK power cord; No printer, basic laser transport cart with base and back panel; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260861 ()
XSCRIBE-6AB-CEAAA

  • Electrocardiographic lead set, reusable
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; Software kit; Australia power cord; No printer, basic laser transport cart with base and back panel; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Server interface (remote database requires XScribe Server)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260724 ()
XSCRIBE-6AC-BEAAC

  • Electrocardiographic lead set, reusable
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; Software kit; International power cord; Z200+ thermal printer (includes starter pack of full-grid paper - A4), no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260588 ()
XSCRIBE-6AC-DBBXA

  • Electrocardiographic lead set, reusable
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259704 ()
XSCRIBE-6CC-DDAAX

  • Electrocardiographic lead set, reusable
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259667 ()
XSCRIBE-6CC-DEBAA

  • Electrocardiographic lead set, reusable
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; Australia power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259063 ()
XSCRIBE-6XC-BXAXA

  • Electrocardiographic lead set, reusable
TM55 Treadmill with E-Stop and Rapid Decel, High Voltage (220V)
WELCH ALLYN, INC.
901085
In Commercial Distribution

  • 00732094257755 ()
TM55HEXRCE

  • Electrocardiographic lead set, reusable
TM55 Treadmill with E-Stop, High Voltage, UK
WELCH ALLYN, INC.
901085
Not in Commercial Distribution

  • 00732094261462 ()
TM55HEXXCB

  • Electrocardiographic lead set, reusable
TM55 Treadmill with E-Stop and Rapid Decel, Low Voltage
WELCH ALLYN, INC.
901085
In Commercial Distribution

  • 00732094261455 ()
TM55LEXRCE

  • Electrocardiographic lead set, reusable
TM65 Treadmill with E-Stop and Rapid Decel, 110 Voltage
WELCH ALLYN, INC.
901085
In Commercial Distribution

  • 00732094261448 ()
TM65LEXRCE

  • Electrocardiographic lead set, reusable
XScribe 5 upgrade to enable use with the WAM Wireless Acquisition Module. Upgrade includes WAM Wireless Acquisition Module, 12 lead AHA lead set, set of 10 adapter clips, UTK wireless receiver.
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261264 ()


  • Electrocardiographic lead set, reusable
XScribe 5 upgrade to enable use with the WAM Wireless Acquisition Module. Upgrade includes WAM Wireless Acquisition Module, 12 lead IEC lead set, set of 10 adapter clips, UTK wireless receiver.
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261257 ()


  • Electrocardiographic lead set, reusable
XScribe 6 upgrade to enable bidirectional DICOM connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261240 ()
UPGXS6-A-DICOM-A

  • Electrocardiographic lead set, reusable
XScribe 6 upgrade to add Rscribe 6 feature
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261233 ()
UPGXS6-A-RSCRIBE-A

  • Electrocardiographic lead set, reusable
XScribe 6 upgrade server interface to convert system to a Client that connects to a remote modality manager database
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261226 ()
UPGXS6-A-SVR-A

  • Electrocardiographic lead set, reusable
XScribe 6 upgrade to enable XML Orders and Report Export Connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261202 ()
UPGXS6-A-XML-A

  • Electrocardiographic lead set, reusable
XScribe 6 upgrade to include the latest version of XScribe 6 software. Upgrade includes WAM Wireless Acquisition Module and patient cable 10 Wire Short IEC
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261196 ()
UPGXS6-B-SW-A

  • Electrocardiographic lead set, reusable
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