MPS 3 Console

GUDID 20634624530106

QUEST MEDICAL INC

Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable
Primary Device ID20634624530106
NIH Device Record Key633399e9-5ef6-4a31-90ef-2d114723870f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMPS 3 Console
Version Model Number5301000
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
GS120634624530106 [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

Devices Manufactured by QUEST MEDICAL INC

20634624530380 - MPS 3 ISO Medical Air Hose Kit2023-10-24
20634624530397 - MPS 3 Drug Pump Cover2023-04-03
20634624101153 - Q2 IV Administration Set2022-12-14
20634624101252 - Q2 IV Administration Set2022-12-14
20634624101306 - Q2 IV Administration Set2022-12-14
20634624601257 - Q2 IV Administration Set2022-12-14
20634624921096 - High-Flow 4-Way Stopcock2022-12-14
20634624921102 - High-Flow 4-Way Stopcock2022-12-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.