VENDYS II

GUDID B546VENDYS1

ENDOTHELIX, INC.

Laser Doppler blood flowmeter Laser Doppler blood flowmeter
Primary Device IDB546VENDYS1
NIH Device Record Key9716bc41-2cbe-42f2-b4b9-4ffd699dc80b
Commercial Distribution Discontinuation2027-04-24
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENDYS II
Version Model NumberJK-001V
Company DUNS614823792
Company NameENDOTHELIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB546VENDYS1 [Primary]

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-24

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