RLV-T Suction Control Device_Nonsterile

GUDID 20634624413256

QUEST MEDICAL INC

Cardiopulmonary bypass system valve, unidirectional flow/pressure control
Primary Device ID20634624413256
NIH Device Record Keyd20174cb-58ad-4568-907c-9fc94afa6173
Commercial Distribution StatusIn Commercial Distribution
Brand NameRLV-T Suction Control Device_Nonsterile
Version Model Number4103205
Company DUNS041810693
Company NameQUEST MEDICAL INC
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-627-0226
EmailCustserv@questmedical.com
Phone1-800-627-0226
EmailCustserv@questmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100634624413252 [Unit of Use]
GS120634624413256 [Primary]
GS190634624413256 [Unit of Use]

FDA Product Code

DWDSuction Control, Intracardiac, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20634624413256]

Ethylene Oxide


[20634624413256]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-13
Device Publish Date2017-09-29

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