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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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5 Lead, Pinch, SPU Shielded ECG Leadwires,50in, Philips Comp, AAMI, 50/BX
Rising Eagle Medical LLC
5PS-050
In Commercial Distribution

  • G0965PS0505 ()
  • G0965PS0500 ()
5PS-050

  • Electrocardiographic lead set, single-use
5 Lead, Pinch, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
Rising Eagle Medical LLC
5PS-030
Not in Commercial Distribution

  • G0965PS0305 ()
  • G0965PS0300 ()
5PS-030

  • Electrocardiographic lead set, single-use
3 Lead, Snap, SPU Shielded ECG Leadwires,50in, Philips Comp, AAMI, 50/BX
Rising Eagle Medical LLC
3SS-050
Not in Commercial Distribution

  • G0963SS0500 ()
  • G0963SS0505 ()
3SS-050

  • Electrocardiographic lead set, single-use
3 Lead, Snap, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
Rising Eagle Medical LLC
3SS-030
Not in Commercial Distribution

  • G0963SS0300 ()
  • G0963SS0305 ()
3SS-030

  • Electrocardiographic lead set, single-use
3 Lead, Pinch, SPU Shielded ECG Leadwires,50in, Philips Comp, AAMI, 50/BX
Rising Eagle Medical LLC
3PS-050
In Commercial Distribution

  • G0963PS0505 ()
  • G0963PS0500 ()
3PS-050

  • Electrocardiographic lead set, single-use
3 Lead, Pinch, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
Rising Eagle Medical LLC
3PS-030
Not in Commercial Distribution

  • G0963PS0305 ()
  • G0963PS0300 ()
3PS-030

  • Electrocardiographic lead set, single-use
3 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020887 ()
V10-0017

  • Electrocardiographic lead set, reusable
3 Lead Integrated ECG Cable (AngioNew® V & VI)
VASOMEDICAL, INC.
Model AngioNew VI
In Commercial Distribution

  • 00817980020870 ()
A12-0033

  • Electrocardiographic lead set, reusable
Portable Case w/Belt for 1303 Recorder
VASOMEDICAL, INC.
Model 1303
In Commercial Distribution

  • 00817980020610 ()
A10-0041

  • Electrocardiographic lead set, reusable
Infared Communication Adaptor
VASOMEDICAL, INC.
Model 1805
In Commercial Distribution

  • 00817980020603 ()
A10-0022

  • Electrocardiographic lead set, reusable
USB SD Card Reader
VASOMEDICAL, INC.
Model 1303
In Commercial Distribution

  • 00817980020597 ()
A10-0015

  • Electrocardiographic lead set, reusable
12-Ch ECG Holter Patient Cable w/10 Leads
VASOMEDICAL, INC.
Model 1304
In Commercial Distribution

  • 00817980020580 ()
A10-0054

  • Electrocardiographic lead set, reusable
3-Ch ECG Holter Patient Cable w/7 Leads
VASOMEDICAL, INC.
Model 1303
In Commercial Distribution

  • 00817980020573 ()
A10-0053

  • Electrocardiographic lead set, reusable
3-Ch ECG Holter Patient Cable w/5 Leads
VASOMEDICAL, INC.
Model 1303
In Commercial Distribution

  • 00817980020566 ()
A10-0052

  • Electrocardiographic lead set, reusable
2GB SD Memory Card
VASOMEDICAL, INC.
Model 1303
In Commercial Distribution

  • 00817980020559 ()
A10-0011

  • Electrocardiographic lead set, reusable
ECG Cable Adaptor (Model TS3 – for use with V10-0017)
VASOMEDICAL, INC.
Model TS3
In Commercial Distribution

  • 00817980020900 ()
V83-0066

  • Electrocardiographic lead set, reusable
3 Lead Integrated ECG Cable (Model TS3–includes adapter)
VASOMEDICAL, INC.
Model TS3
In Commercial Distribution

  • 00817980020894 ()
V10-0021

  • Electrocardiographic lead set, reusable
Portable case with Belt for 2301/2302 Recorders
VASOMEDICAL, INC.
Model 2301
In Commercial Distribution

  • 00817980020641 ()
A10-0043

  • Electrocardiographic lead set, reusable
Portable case with Belt for 1805 Monitor
VASOMEDICAL, INC.
Model 1303
In Commercial Distribution

  • 00817980020634 ()
A10-0050

  • Electrocardiographic lead set, reusable
Portable case with Belt for 1304/1305 Recorder
VASOMEDICAL, INC.
Model 1304
In Commercial Distribution

  • 00817980020627 ()
A10-0042

  • Electrocardiographic lead set, reusable
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