GUDID 30613994010446

RESERVOIR 61399401044 1EA BLADDER R38

MEDTRONIC, INC.

Cardiotomy reservoir
Primary Device ID30613994010446
NIH Device Record Keye7298398-6985-48aa-9bc5-3b5f8ad5eab7
Commercial Distribution Discontinuation2018-07-23
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number61399401044
Company DUNS006261481
Company NameMEDTRONIC, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS130613994010446 [Primary]
GS150613994010440 [Package]
Package: PK [5 Units]
Discontinued: 2018-07-23
Not in Commercial Distribution
GS170613994010444 [Package]
Contains: 50613994010440
Package: CT [4 Units]
Discontinued: 2018-07-23
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTNRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-22
Device Publish Date2017-05-06

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