GUDID 20763000528540

CUSTOM PACK 11N36R4 5PK PROCUREMENT PAC

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set
Primary Device ID20763000528540
NIH Device Record Key859f07a2-918d-43f0-ab38-763fc406c9d7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number11N36R4
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 Kittrue
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 Perscriptiontrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
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
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
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
GS100763000528539 [Primary]
GS120763000528540 [Package]
Contains: 00763000528539
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-12-08
Device Publish Date2021-04-10

Devices Manufactured by MEDTRONIC, INC.

20199150004151 - NA2025-04-07 CUSTOM PACK BB10V58R1 10PK SHELBY BPT PG
20199150004311 - NA2025-04-07 CUSTOM PACK BB12P29R 4PK TABLE LNS
00763000959616 - AEX2025-04-04 AEX GENERATOR 40-405-1R REFURB US
20763000651736 - Aortic Punch2025-03-31 Aortic Punch APU425 - 2.5mm punch size
20763000651743 - Aortic Punch2025-03-31 Aortic Punch APU430 - 3.0mm punch size
20763000651750 - Aortic Punch2025-03-31 Aortic Punch APU435 - 3.5mm punch size
20763000651767 - Aortic Punch2025-03-31 Aortic Punch APU440 - 4.0mm punch size
20763000651774 - Aortic Punch2025-03-31 Aortic Punch APU444 - 4.4mm punch size

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.