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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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MyCareLink™ - 00643169469884

MONITOR 24955 FRU US CAN ANZ EUR 1 BD
MEDTRONIC, INC.
24955
Not in Commercial Distribution

  • 00643169469884 ()


  • Cardiac pulse generator reader, home-use

Carelink - 00643169460089

MON 2490G24 CARELINK MR6 RFB
MEDTRONIC, INC.
2490G24
Not in Commercial Distribution

  • 00643169460089 ()


  • Cardiac pulse generator reader, home-use

MyCareLink™ - 00643169452060

MON 24950E MYCARELINK/SVC USA
MEDTRONIC, INC.
24950E
In Commercial Distribution

  • 00643169452060 ()


  • Cardiac pulse generator reader, home-use

MyCareLink™ - 00643169441101

MON 24950D MYCARELINK US M2.0
MEDTRONIC, INC.
24950D
Not in Commercial Distribution

  • 00643169441101 ()


  • Cardiac pulse generator reader, home-use

CARELINK® MONITOR - 00643169459885

MON 2490G24 CARELINK MR6 USA
MEDTRONIC, INC.
2490G24
In Commercial Distribution

  • 00643169459885 ()


  • Cardiac pulse generator reader, home-use

Vivio System App - 00850044849024

No Description
Ventric Health
VA 1.0
In Commercial Distribution

  • 00850044849024 ()


  • Cardiac mapping system application software

CareLink® Network - 00643169496460

SW CLN04 CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN04
Not in Commercial Distribution

  • 00643169496460 ()


  • Cardiac pulse generator reader, professional

MyCareLink™ - 00643169486744

MON 24950D1 MYCARELINK/SVC MKT USA
MEDTRONIC, INC.
24950D1
Not in Commercial Distribution

  • 00643169486744 ()


  • Cardiac pulse generator reader, home-use

ExSpiron 1Xi - 00851540007055

Assembly designed to be integrated into medical facility infrastructure in order to trigger a nurse call alarm system. Designed to be used only with the ExSpiron 1Xi Monitor.
Respiratory Motion Inc.
Nurse Call Module
In Commercial Distribution

  • 00851540007055 ()
  • 00851540007079 ()
RMI-51155

  • Nurse call system

EMAS (Eko Murmur Analysis Software) - 00850010298184

The Eko Murmur Analysis Software is intended to provide decision support to clinicians in their evaluation of patients’ heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur.
Eko Devices, Inc.
Version 1.x
In Commercial Distribution

  • 00850010298184 ()
EMAS

  • Cardiopulmonary physiological parameter analysis software
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