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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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SphygmoCor - 19351315000017

Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others]. CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL: • CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)] • CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)].
ATCOR MEDICAL PTY LTD
CVMS
In Commercial Distribution

  • 19351315000017 ()
  • 19351315000024 ()


  • Patient monitoring system module, multifunction

Medtronic CareLink® Programmer - 00613994127631

PROGRAMMER 2090W Tel C UPGRADE US
MEDTRONIC, INC.
2090W
Not in Commercial Distribution

  • 00613994127631 ()


  • Cardiac pulse generator programmer

NA - 00613994119995

WIRELESS ETHERNET 2091WB (802.11B) US MR
MEDTRONIC, INC.
2091WB
In Commercial Distribution

  • 00613994119995 ()


  • Cardiac pulse generator programmer

NA - 04546540392091

INSTRUMENT TRACKER
Stryker Leibinger GmbH & Co. KG
6007-008-000
In Commercial Distribution

  • 04546540392091 ()
6007-008-000

  • Sensor holder, reusable

Hand adapter TOF3D - 04255629200430

No Description
MIPM Mammendorfer Institut für Physik und Medizin GmbH
5750100
In Commercial Distribution

5750100

  • Sensor holder, reusable

FUKUDA DENSHI - 04538612913792

No Description
FUKUDA DENSHI CO.,LTD.
FSD-8GA
In Commercial Distribution

  • 04538612913792 ()


  • Data storage card

FUKUDA DENSHI - 04538612913785

No Description
FUKUDA DENSHI CO.,LTD.
SD-16G
In Commercial Distribution

  • 04538612913785 ()


  • Data storage card

FUKUDA DENSHI - 04538612913778

No Description
FUKUDA DENSHI CO.,LTD.
FCS-64G
In Commercial Distribution

  • 04538612913778 ()


  • Data storage card

FUKUDA DENSHI - 04538612911231

No Description
FUKUDA DENSHI CO.,LTD.
FCF-16GA
In Commercial Distribution

  • 04538612911231 ()


  • Data storage card

FUKUDA DENSHI - 04538612911224

No Description
FUKUDA DENSHI CO.,LTD.
FCF-1000
In Commercial Distribution

  • 04538612911224 ()


  • Data storage card
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