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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System, AngioNew V, 220V
VASOMEDICAL, INC.
Model AngioNew V
In Commercial Distribution

  • 00817980020757 ()
A12-0002

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

  • 00817980020740 ()
A12-0001

  • 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 TS4 and Lumenair™)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021365 ()
V10-0014

  • 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 (Newer AngioNew® V and VI)
VASOMEDICAL, INC.
Model AngioNew VI
In Commercial Distribution

  • 00817980021341 ()
A12-0037

  • Pulse oximeter, line-powered
Spo2 Probe (Older AngioNew® V and VI)
VASOMEDICAL, INC.
Model AngioNew VI
In Commercial Distribution

  • 00817980021334 ()
A12-0035

  • Pulse oximeter, line-powered
Spo2 Probe (Lumenair™ and Model TS4)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021327 ()
V83-0253

  • 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, (300mm) (AngioNew® VI)
VASOMEDICAL, INC.
Model AngioNew VI
In Commercial Distribution

  • 00817980021303 ()
A12-0044-0

  • 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, Complete Set, Calf, Upper Thigh & Lower Thigh (AngioNew® V)
VASOMEDICAL, INC.
Model AngioNew V
In Commercial Distribution

  • 00817980021280 ()
A12-0047

  • 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, Single, (Models MC2, TS3, TS4 and Lumenair for Lower Thigh And Calf)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021266 ()
V53-0087-0

  • 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
Hose, Set of 6 (Lumenair™)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021242 ()
V23-0075-0

  • External counterpulsation system, stationary
TwiLoK™ System Adapter for Hose (inserted into system table)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021235 ()
V53-0084

  • External counterpulsation system, stationary
TwiLoK™ Cuff Side Hose Connector
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021228 ()
V31-0267

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

  • 00817980021211 ()
V23-0006

  • External counterpulsation system, stationary
Finger Plethysmograph (Model MC2, AngioNew® V& VI)
VASOMEDICAL, INC.
Model AngioNew VI
In Commercial Distribution

  • 00817980021204 ()
V23-0007

  • Plethysmography phototransducer
Finger Plethysmograph (Models TS3 and TS4)
VASOMEDICAL, INC.
Model TS-4
In Commercial Distribution

  • 00817980021198 ()
V83-0006

  • Plethysmography phototransducer
Treatment Pants, XX-Large
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021181 ()
V10-0011

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

  • 00817980021174 ()
V23-0022-6

  • External counterpulsation system, stationary
Treatment Pants, Large
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021167 ()
V23-0022-5

  • External counterpulsation system, stationary
Treatment Pants, Medium
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021150 ()
V23-0022-4

  • External counterpulsation system, stationary
Treatment Pants, Small
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021143 ()
V23-0022-3

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

  • 00817980021136 ()
V23-0022-2

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

  • 00817980021129 ()
V23-0010

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

  • 00817980021112 ()
V23-0012

  • External counterpulsation system, stationary
Bladder Set, X-Large (should be used with XL and XXL cuffs)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980021105 ()
V23-0022-1

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

  • 00817980021099 ()
V23-0011

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

  • 00817980021082 ()
V23-0013

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

  • 00817980021075 ()
V10-0023-6

  • External counterpulsation system, stationary
No Description
Vista Dental
90782
In Commercial Distribution

  • 00818207020987 ()
  • 10818207020984 ()


  • Dental restoration fixation cleaning solution
Lid implant (lid chain) Platinum/Iridium according to Berghaus/Schrom, 2.2 g, sterile, 1 piece
Spiggle & Theis Medizintechnik GmbH
1500-22
In Commercial Distribution

  • 04250381893005 ()

  • Weight: 2.2 Gram
1500-22

  • Eyelid weight, implantable
No Description
Chongqing PSK-Health Sci-Tech Development Co.,Ltd.
PECP/TM
In Commercial Distribution

  • 06971379470074 ()


  • External counterpulsation system, mobile
No Description
Chongqing PSK-Health Sci-Tech Development Co.,Ltd.
PECP/TI
In Commercial Distribution

  • 06971379470067 ()


  • External counterpulsation system, stationary
No Description
Chongqing PSK-Health Sci-Tech Development Co.,Ltd.
P-ECP/TI
Not in Commercial Distribution

  • 06971379470029 ()


  • External counterpulsation system, stationary
No Description
Chongqing PSK-Health Sci-Tech Development Co.,Ltd.
P-ECP/TM
Not in Commercial Distribution

  • 06971379470012 ()


  • External counterpulsation system, mobile
EPG 5392 USA FW/IFU UPDATE
MEDTRONIC, INC.
5392
In Commercial Distribution

  • 00763000162443 ()


  • External pacemaker, epicardial pacing
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