MPS

GUDID 20634624501182

MPS® Antegrade/Retrograde Y-Set

QUEST MEDICAL INC

Cardioplegia solution administration kit
Primary Device ID20634624501182
NIH Device Record Keydbb0dc2e-adf9-4c6b-9132-26cb179504a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMPS
Version Model Number5001108
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
GS100634624501188 [Primary]
GS120634624501182 [Package]
Contains: 00634624501188
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 Date2015-09-16

On-Brand Devices [MPS]

20634624551170MPS® Retrograde extension line without transducer
20634624551132MPS® Pressure Line w/transducer
20634624551125MPS® Retrograde extension pressure line w/Y-set
20634624551118MPS® Retrograde external pressure line w/pressure transducer
20634624521128MPS® Delivery Set with 6 ft. delivery tubing
20634624501182MPS® Antegrade/Retrograde Y-Set
20634624501168MPS® Extension Line (10 ft. x 3/16 in. ID)
20634624501151MPS® Additive Agent Cassette
20634624501144MPS® Arrest Agent Cassette
20634624501137MPS Delivery Set with arrest agent or additive cassettes, 183 cm extension line
20634624501120MPS® Delivery Set w/arrest agent and additive cassettes, heat exchanger & 10 ft. delivery tubin
20634624501113MPS Water Circuit Adapter
20634624500116Dual Spike Crystalloid Y Adapter

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