VasoPrep Vein Preparation Kit

GUDID 00860002037813

VasoPrep Vein Preparation Kit

VASOPREP SURGICAL, LLC

Vein irrigation/distention set
Primary Device ID00860002037813
NIH Device Record Keyf27786af-86d1-4613-8335-89e644917d2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVasoPrep Vein Preparation Kit
Version Model NumberVAP-VSR-0002
Company DUNS078468395
Company NameVASOPREP SURGICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-433-7884
Emailgsohie@vasoprep.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002037813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GBXCatheter, Irrigation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-30
Device Publish Date2019-08-22

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