MPS® Mini-Prime Delivery Set

GUDID 00634624701113

MPS® Mini-Prime Delivery Set with Arrest and Additive Cassettes

QUEST MEDICAL INC

Cardioplegia solution administration kit
Primary Device ID00634624701113
NIH Device Record Key043efd1f-b4f2-4249-86ea-6091f0ed3276
Commercial Distribution StatusIn Commercial Distribution
Brand NameMPS® Mini-Prime Delivery Set
Version Model Number7001101
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100634624701113 [Primary]
GS120634624701117 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTRHeat-Exchanger, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-06

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