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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Thigh Cuff, Large
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021013 ()
V10-0022-4

  • External counterpulsation system, stationary
Thigh Cuff, Medium
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021006 ()
V10-0022-3

  • External counterpulsation system, stationary
Thigh Cuff, Small
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020993 ()
V10-0022-2

  • External counterpulsation system, stationary
Thigh Cuff, X-Small
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020986 ()
V10-0022-1

  • External counterpulsation system, stationary
Cuff Set, XX-Large
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020979 ()
V23-0077

  • External counterpulsation system, stationary
Cuff Set, X-Large
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020962 ()
V23-0001

  • External counterpulsation system, stationary
Cuff Set, Large
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020955 ()
V23-0002

  • External counterpulsation system, stationary
Cuff Set, Medium
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020948 ()
V23-0003

  • External counterpulsation system, stationary
Cuff Set, Small
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020931 ()
V23-0004

  • External counterpulsation system, stationary
Electrodes (600 per case)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020917 ()
V93-0020

  • Electrocardiographic electrode, single-use
System, AngioNew VI, 220V
VASOMEDICAL, INC.
Model AngioNew VI
In Commercial Distribution

  • 00817980020771 ()
A12-0004

  • External counterpulsation system, mobile
System, AngioNew V, 220V
VASOMEDICAL, INC.
Model AngioNew V
In Commercial Distribution

  • 00817980020757 ()
A12-0002

  • External counterpulsation system, stationary
Patient Stop Cable (AngioNew® V and VI)
VASOMEDICAL, INC.
Model AngioNew VI
In Commercial Distribution

  • 00817980021372 ()
A12-0036

  • External counterpulsation system, stationary
Patient Stop Cable (Model TS3)
VASOMEDICAL, INC.
Model TS3
In Commercial Distribution

  • 00817980021358 ()
V10-0012

  • External counterpulsation system, stationary
Spo2 Probe (Older AngioNew® V and VI)
VASOMEDICAL, INC.
Model AngioNew VI
In Commercial Distribution

  • 00817980021334 ()
A12-0035

  • Pulse oximeter, line-powered
Hose, Set of 6 (AngioNew® VI)
VASOMEDICAL, INC.
Model AngioNew VI
In Commercial Distribution

  • 00817980021310 ()
A12-0046-0

  • External counterpulsation system, stationary
Hose Single, (250mm) (AngioNew® VI)
VASOMEDICAL, INC.
Model AngioNew VI
In Commercial Distribution

  • 00817980021297 ()
A12-0045-0

  • External counterpulsation system, stationary
Hose, Single, Upper Thigh (Lumenair™)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021273 ()
V53-0086-0

  • External counterpulsation system, stationary
Hose, Set of 6 (Models MC2, TS3, TS4)
VASOMEDICAL, INC.
Model TS-4
In Commercial Distribution

  • 00817980021259 ()
V23-0078-0

  • External counterpulsation system, stationary
Bladder Set, Large
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021129 ()
V23-0010

  • External counterpulsation system, stationary
Calf Cuff, XX-Large
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021075 ()
V10-0023-6

  • External counterpulsation system, stationary
Cuff Set, X-Small
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020924 ()
V23-0005

  • External counterpulsation system, stationary
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
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
Signa Electrode Gel, 2 oz
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020863 ()
V93-0026-1

  • Electrode conductive medium
Signa Electrode Gel, 8 oz
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020856 ()
V93-0026

  • Electrode conductive medium
Nu Prep Gel, 4 oz (3 PK)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020849 ()
V93-0025-1

  • Electrode conductive medium
Roll ECG Paper, 240 ft. (Model MC2)
VASOMEDICAL, INC.
Model MC2
In Commercial Distribution

  • 00817980020832 ()
2-128

  • External counterpulsation system, stationary
Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020825 ()
V93-0003

  • External counterpulsation system, stationary
System, TS-4 - Reconditioned
VASOMEDICAL, INC.
Model TS-4
In Commercial Distribution

  • 00817980020818 ()
R10-0000

  • External counterpulsation system, stationary
System, TS-4
VASOMEDICAL, INC.
Model TS-4
In Commercial Distribution

  • 00817980020801 ()
V10-0000

  • External counterpulsation system, stationary
System, Lumenair - Reconditioned
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020795 ()
R10-0020-1

  • External counterpulsation system, stationary
System, Lumenair
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020788 ()
V10-0020-1

  • External counterpulsation system, stationary
System, AngioNew VI, 110V
VASOMEDICAL, INC.
Model AngioNew VI
In Commercial Distribution

  • 00817980020764 ()
A12-0003

  • External counterpulsation system, mobile
System, AngioNew V, 110V
VASOMEDICAL, INC.
Model AngioNew V
In Commercial Distribution

  • 00817980020740 ()
A12-0001

  • External counterpulsation system, stationary
Cavity Varnish, Dental.
DENALI CORPORATION
Single - Pink
In Commercial Distribution

  • D820RCG0 ()
  • D820RCG1 ()
RCG

  • Dental cavity varnish
Lid-Chain Berghaus/Schrom 1.8GM
JEDMED INSTRUMENT COMPANY
28-1518
In Commercial Distribution

  • M6332815180 ()

  • Weight: 1.8 Gram
28-1518

  • Eyelid weight, implantable
Lid-Chain Berghaus/Schrom 1.6GM
JEDMED INSTRUMENT COMPANY
28-1516
In Commercial Distribution

  • M6332815160 ()

  • Weight: 1.6 Gram
28-1516

  • Eyelid weight, implantable
Lid-Chain Berghaus/Schrom 1.4GM
JEDMED INSTRUMENT COMPANY
28-1514
In Commercial Distribution

  • M6332815140 ()

  • Weight: 1.4 Gram
28-1514

  • Eyelid weight, implantable
Lid-Chain Berghaus/Schrom 1.2GM
JEDMED INSTRUMENT COMPANY
28-1512
In Commercial Distribution

  • M6332815120 ()

  • Weight: 1.2 Gram
28-1512

  • Eyelid weight, implantable
Lid-Chain Berghaus/Schrom 1.0GM
JEDMED INSTRUMENT COMPANY
28-1510
In Commercial Distribution

  • M6332815100 ()

  • Weight: 1.0 Gram
28-1510

  • Eyelid weight, implantable
Lid-Chain Berghaus/Schrom 0.8GM
JEDMED INSTRUMENT COMPANY
28-1508
In Commercial Distribution

  • M6332815080 ()

  • Weight: 0.8 Gram
28-1508

  • Eyelid weight, implantable
Lid-Chain Berghaus/Schrom 0.6GM
JEDMED INSTRUMENT COMPANY
28-1506
In Commercial Distribution

  • M6332815060 ()

  • Weight: 0.6 Gram
28-1506

  • Eyelid weight, implantable
No Description
DEFIBTECH, L.L.C.
RPP-U2000
In Commercial Distribution

  • 00815098020836 ()


  • Cardiac resuscitator, battery-powered
No Description
DEFIBTECH, L.L.C.
RMC-U2000
In Commercial Distribution

  • 00815098020812 ()


  • Cardiac resuscitator, battery-powered
ThinProfile Platinum Eyelid Weight Implant 1.8 g
MEDDEV CORPORATION
LL6018
In Commercial Distribution

  • 00813142020726 ()
LL6018

  • Eyelid weight, implantable
ThinProfile Platinum Eyelid Weight Implant 1.4 g
MEDDEV CORPORATION
LL6014
In Commercial Distribution

  • 00813142020702 ()
LL6014

  • Eyelid weight, implantable
ThinProfile Platinum Eyelid Weight Implant 1.0 g
MEDDEV CORPORATION
LL6010
In Commercial Distribution

  • 00813142020689 ()
LL6010

  • Eyelid weight, implantable
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