TwiLoK™ System Adapter for Hose (inserted into system table) V53-0084

GUDID 00817980021235

TwiLoK™ System Adapter for Hose (inserted into system table)

VASOMEDICAL, INC.

External counterpulsation system, stationary
Primary Device ID00817980021235
NIH Device Record Keyadc9e709-fd2a-4fc9-a20c-7803ae9fad09
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwiLoK™ System Adapter for Hose (inserted into system table)
Version Model NumberModel Lumenair
Catalog NumberV53-0084
Company DUNS197210248
Company NameVASOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(516)508-5818
Emaileohara@vasomedical.com
Phone+1(516)508-5818
Emaileohara@vasomedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817980021235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRNDevice, counter-pulsating, external

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-29

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