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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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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 + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259650 ()
XSCRIBE-6CC-DEBAB

  • 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; 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; Server interface (remote database requires XScribe Server)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259643 ()
XSCRIBE-6CC-DEBAC

  • 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; 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; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259629 ()
XSCRIBE-6CC-DEBXA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module; Software kit; US/Canada power cord; No printer, no transport cart; 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

  • 00732094259421 ()
XSCRIBE-6DC-AXAAA

  • 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; Software kit; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259254 ()
XSCRIBE-6EC-DXBXX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module with Trigger Module for TTL/analog signal output and RScribe with Interpretation; Software kit; International power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259223 ()
XSCRIBE-6FC-DXBXX

  • 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 and RScribe with Interpretation; 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; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259179 ()
XSCRIBE-6GC-DEBXB

  • Cardiopulmonary stress exercise monitoring system computer
CD103 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB28640 ()
BSB 2864

  • CD103 cell marker IVD, antibody
PC based software required a) to configure special (safety-relevant) settings of the SenTec Digital Monitor (SDM), b) to manage ‘SDM Parameters Settings’ and c) to download trend data from the internal memory of the SDM to a PC. It includes features to analyze and view the downloaded trend data. The V-STATS™ software includes the V-CareNeT™ Package, which enables remote monitoring and alarm surveillance for multiple SDMs being connected to the same network as the PC with V-STATS™.
SenTec AG
V-STATS_CD
In Commercial Distribution

  • 07640121880773 ()


  • Transcutaneous blood gas monitoring system
  • Transcutaneous blood gas monitor sensor
  • Pulse Co-oximeter probe, reusable
Softshell Venous Reser. 1900ml w. connector 700000292, BO-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BO-T 39705
In Commercial Distribution

  • 00607567211490 ()
709000415

  • Cardiopulmonary bypass system blood tubing set
Softshell Venous Reser. 1900ml w. connector 700000292, BEQ-RF32 RotaFlow,Gas Filter
DATASCOPE CORP.
BEQ-T 39705
In Commercial Distribution

  • 00607567211483 ()
709000414

  • Cardiopulmonary bypass system blood tubing set
ROTATION ROD 653001500 500 X 5.5MM TI AL
MEDTRONIC SOFAMOR DANEK, INC.
653001500
In Commercial Distribution

  • 00643169623422 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 500.0 Millimeter


  • Bone-screw internal spinal fixation system rod
ROTATION ROD 651001480 480 X 5.5MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
651001480
In Commercial Distribution

  • 00643169607873 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 480.0 Millimeter


  • Bone-screw internal spinal fixation system rod
ROTATION ROD 651001440 440 X 5.5MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
651001440
In Commercial Distribution

  • 00643169607859 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 440.0 Millimeter


  • Bone-screw internal spinal fixation system rod
ROTATION ROD 651001420 420 X 5.5MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
651001420
In Commercial Distribution

  • 00643169607842 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 420.0 Millimeter


  • Bone-screw internal spinal fixation system rod
ROTATION ROD 651001400 400 X 5.5MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
651001400
In Commercial Distribution

  • 00643169607835 ()

  • Length: 400.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod
ROTATION ROD 651001380 380 X 5.5MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
651001380
In Commercial Distribution

  • 00643169607828 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 380.0 Millimeter


  • Bone-screw internal spinal fixation system rod
ROTATION ROD 651001360 360 X 5.5MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
651001360
In Commercial Distribution

  • 00643169607811 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 360.0 Millimeter


  • Bone-screw internal spinal fixation system rod
ROTATION ROD 651001320 320 X 5.5MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
651001320
In Commercial Distribution

  • 00643169607798 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 320.0 Millimeter


  • Bone-screw internal spinal fixation system rod
ROTATION ROD 651001300 300 X 5.5MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
651001300
In Commercial Distribution

  • 00643169607781 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 300.0 Millimeter


  • Bone-screw internal spinal fixation system rod
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