GUDID 20199150004120

CUSTOM PACK BB9R13R13 4PK PLEG PACK

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set
Primary Device ID20199150004120
NIH Device Record Key3d976da3-ba9b-4705-9a18-6f6e9a7ae0cc
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBB9R13R13
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
GS100199150004119 [Primary]
GS120199150004120 [Package]
Contains: 00199150004119
Package: PK [4 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.

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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 - NA2025-04-11 CUSTOM PACK BB7U92R3 5PK BRIDGE PK
20199150004083 - NA2025-04-11 CUSTOM PACK BB10V11R1 5PK EXTENSION LIN
20199150004120 - NA2025-04-11CUSTOM PACK BB9R13R13 4PK PLEG PACK
20199150004120 - NA2025-04-11 CUSTOM PACK BB9R13R13 4PK PLEG PACK

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