MPS Hypothermic Reservoir

GUDID 20634624510085

QUEST MEDICAL INC

Cardiopulmonary bypass system heat exchanger, reusable
Primary Device ID20634624510085
NIH Device Record Keyee623fe2-6a98-4f75-be7b-fe0abaa3d875
Commercial Distribution StatusIn Commercial Distribution
Brand NameMPS Hypothermic Reservoir
Version Model Number5001001G
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 Batchfalse
Serial Numbertrue
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
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS120634624510085 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-04
Device Publish Date2020-07-27

On-Brand Devices [MPS Hypothermic Reservoir]

206346245100165001001
206346245100855001001G

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