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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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Rhythmia™ Mapping System - 08714729841692

ECG Cable - Trunk - US AAMI
BOSTON SCIENTIFIC CORPORATION
M004RA5000US0
In Commercial Distribution

  • 08714729841692 ()


  • Electrocardiographic lead set, reusable

Nuubo System - 08437011759030

Nuubo30 SIII Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.
SMART SOLUTIONS TECHNOLOGIES SL
2022
In Commercial Distribution

  • 08437011759030 ()
2022

  • Electrocardiographic lead set, single-use

Nuubo System - 08437011759023

Nuubo30 SII Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.
SMART SOLUTIONS TECHNOLOGIES SL
2021
In Commercial Distribution

  • 08437011759023 ()
2021

  • Electrocardiographic lead set, single-use

Nuubo System - 08437011759016

Nuubo30 SI Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.
SMART SOLUTIONS TECHNOLOGIES SL
2020
In Commercial Distribution

  • 08437011759016 ()
2020

  • Electrocardiographic lead set, single-use

HFVI-SC-V1 - 03760232460283

The patient cable is used to connect the HFVI Sensor (UDI number 03760232460245) to the acquisition box BA-HFVI-V1 (UDI number 03760232460184)
MDOLORIS MEDICAL SYSTEMS
1
In Commercial Distribution

  • 03760232460283 ()


  • Electrocardiographic lead set, reusable

DDU-2XXX Series ECGMA Cable, IEC Configuration - 10815098020529

No Description
DEFIBTECH, L.L.C.
DAC-2021
In Commercial Distribution

  • 10815098020529 ()


  • Electrocardiographic lead set, reusable

DDU-2XXX Series ECGMA Cable, AAMI Configuration - 10815098020512

No Description
DEFIBTECH, L.L.C.
DAC-2020
In Commercial Distribution

  • 10815098020512 ()


  • Electrocardiographic lead set, reusable

DDU-1XXX/2XXX Adult Pads Adapter, Zoll Configuration - 10815098020505

No Description
DEFIBTECH, L.L.C.
DAC-2010
In Commercial Distribution

  • 10815098020505 ()


  • Electrocardiographic lead set, reusable

DDU-1XXX/2XXX Adult Pads Adapter, Physio-Control Configuration - 10815098020499

No Description
DEFIBTECH, L.L.C.
DAC-2000
In Commercial Distribution

  • 10815098020499 ()


  • Electrocardiographic lead set, reusable

DDU-1XX Series Adult Pads Adapter, Zoll Configuration - 10815098020482

No Description
DEFIBTECH, L.L.C.
DAC-310E
In Commercial Distribution

  • 10815098020482 ()


  • Electrocardiographic lead set, reusable

DDU-1XX Series Adult Pads Adapter, Physio-Control Configuration - 10815098020475

No Description
DEFIBTECH, L.L.C.
DAC-300E
In Commercial Distribution

  • 10815098020475 ()


  • Electrocardiographic lead set, reusable

Ameritus - 10817522010366

small size ecg electrode
KENTEC MEDICAL, INC.
AMG-503-SM
In Commercial Distribution

  • 20817522010363 ()
  • 10817522010366 ()
AMG-503-SM

  • Electrocardiographic lead set, single-use

Ameritus - 10817522010359

large size ecg electrode
KENTEC MEDICAL, INC.
AMG-503-LG
In Commercial Distribution

  • 20817522010356 ()
  • 10817522010359 ()
AMG-503-LG

  • Electrocardiographic lead set, single-use

Kentec electrode - 10817522013336

5-lead electrode
KENTEC MEDICAL, INC.
AMG-503-PED
In Commercial Distribution

  • 20817522013333 ()
  • 10817522013336 ()
AMG-503-PED

  • Electrocardiographic lead set, reusable

Med-Dyne - 10817497020667

60" GOLD CUP ELECTRODE - BLACK LEAD WIRE - SET OF 12
MED-DYNE, INC.
GBK60-12
In Commercial Distribution

  • 10817497020667 ()

  • Length: 60 Inch


  • Electrocardiographic lead set, single-use

RHYTHMIA HDx™ - 08714729938620

CardioLab™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9100ECG60
In Commercial Distribution

  • 08714729938620 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938613

CardioLab™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9100ECG30
In Commercial Distribution

  • 08714729938613 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938569

Clearsign™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9000ECG60
In Commercial Distribution

  • 08714729938569 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938552

Clearsign™ Direct Connect ECG
BOSTON SCIENTIFIC CORPORATION
M004RA9000ECG30
In Commercial Distribution

  • 08714729938552 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938538

ECG IN Cable (Limb and Chest)
BOSTON SCIENTIFIC CORPORATION
M004RA5110I0
In Commercial Distribution

  • 08714729938538 ()


  • Electrocardiographic lead set, reusable
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