MPS 3 Delivery Set w/AA w/106cm (10C)

GUDID 20634624500338

QUEST MEDICAL INC

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Primary Device ID20634624500338
NIH Device Record Key8a2aa371-a8d3-4d61-a6a4-d61fc0977095
Commercial Distribution StatusIn Commercial Distribution
Brand NameMPS 3 Delivery Set w/AA w/106cm (10C)
Version Model Number5003103
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 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

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
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
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
GS100634624500334 [Primary]
GS120634624500338 [Package]
Contains: 00634624500334
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWCController, Temperature, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-04
Device Publish Date2020-07-27

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