GUDID 20199150020717

CUSTOM PACK BB3G62R1 5PK SUPP SUCKR

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set
Primary Device ID20199150020717
NIH Device Record Keyea4e09c9-947d-428d-96a2-efb19f4cce01
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBB3G62R1
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
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
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
GS100199150020706 [Primary]
GS120199150020717 [Package]
Contains: 00199150020706
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 Date2025-05-26
Device Publish Date2025-05-16

Devices Manufactured by MEDTRONIC, INC.

20199150019568 - NA2025-05-26 CUSTOM PACK BB11V60R1 20PK VUMC PIGTAILS
20199150019582 - NA2025-05-26 CUSTOM PACK BB4P07R2 2PK PLEG LIN
20199150020717 - NA2025-05-26CUSTOM PACK BB3G62R1 5PK SUPP SUCKR
20199150020717 - NA2025-05-26 CUSTOM PACK BB3G62R1 5PK SUPP SUCKR
00763000841607 - Cardioblate™ Gemini™-s2025-05-26 CLAMP 49351 CARDIOBLATE GEMINI-S FT
00199150018154 - NA2025-05-23 CUSTOM PACK BB10N41R2 SUPPORT SM
00199150019618 - NA2025-05-23 CUSTOM PACK BB12Q14R ADULT OXY/TIES
00199150019625 - NA2025-05-23 CUSTOM PACK BB9N98R17 PUMP PACK
00199150019632 - NA2025-05-23 CUSTOM PACK BB11P48R5 ATTRNSFN SET

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