MPS Console Adapter, base mount

GUDID 20634624500253

QUEST MEDICAL INC

Cardiopulmonary bypass system heat exchanger, reusable
Primary Device ID20634624500253
NIH Device Record Keyc7a6bcd0-6fdd-405f-bf47-4c4c3101061b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMPS Console Adapter, base mount
Version Model Number5001025
Company DUNS041810693
Company NameQUEST MEDICAL 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 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
GS120634624500253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTRHeat-Exchanger, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2019-10-10

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