GUDID 30613994010439

RESERVOIR 61399401043 1EA BLADDER R14

MEDTRONIC, INC.

Cardiotomy reservoir
Primary Device ID30613994010439
NIH Device Record Key546648f8-86fb-48fd-ab5c-5328f86015ef
Commercial Distribution Discontinuation2018-07-23
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number61399401043
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
GS130613994010439 [Primary]
GS150613994010433 [Package]
Package: PK [5 Units]
Discontinued: 2018-07-23
Not in Commercial Distribution
GS170613994010437 [Package]
Contains: 50613994010433
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

Devices Manufactured by MEDTRONIC, INC.

00763000906160 - Launcher™2024-07-22 CATHETER LA6JR40K LA 6F 55CM JR40
20763000770291 - TrailBlazer™2024-07-16 PS ASC-014-090 TRAILBLAZER ANGLED V04
20763000770307 - TrailBlazer™2024-07-16 PS ASC-014-135 TRAILBLAZER ANGLED V04
20763000770314 - TrailBlazer™2024-07-16 PS ASC-014-150 TRAILBLAZER ANGLED V04
20763000770321 - TrailBlazer™2024-07-16 PS ASC-018-090 TRAILBLAZER ANGLED V04
20763000770338 - TrailBlazer™2024-07-16 PS ASC-018-135 TRAILBLAZER ANGLED V04
20763000770345 - TrailBlazer™2024-07-16 PS ASC-018-150 TRAILBLAZER ANGLED V04
20763000770352 - TrailBlazer™2024-07-16 PS ASC-035-065 TRAILBLAZER ANGLED V04

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