GUDID 20199150004069

CUSTOM PACK BB7U92R3 5PK BRIDGE PK

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set
Primary Device ID20199150004069
NIH Device Record Keyf1c2a606-4a02-4c93-913b-d31cc9fc3dd7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBB7U92R3
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
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
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
GS100199150004058 [Primary]
GS120199150004069 [Package]
Contains: 00199150004058
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-11
Device Publish Date2025-04-03

Devices Manufactured by MEDTRONIC, INC.

00199150003624 - NA2025-04-11 CUSTOM PACK BB5723R37 CHR LINF
00199150003631 - NA2025-04-11 CUSTOM PACK BB11Y69R2 SATELLITE
00199150003969 - NA2025-04-11 CUSTOM PACK BB10Z37R8 PEDS PACK
00199150003976 - NA2025-04-11 CUSTOM PACK BB11R40R1 TRANS PORT
00199150004041 - NA2025-04-11 CUSTOM PACK BB8D33R18 PUMP PK
20199150004069 - NA2025-04-11CUSTOM PACK BB7U92R3 5PK BRIDGE PK
20199150004069 - NA2025-04-11 CUSTOM PACK BB7U92R3 5PK BRIDGE PK
20199150004083 - NA2025-04-11 CUSTOM PACK BB10V11R1 5PK EXTENSION LIN
20199150004120 - NA2025-04-11 CUSTOM PACK BB9R13R13 4PK PLEG PACK

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