GUDID 00763000344511

CUSTOM PACK CB6L58R2 CP PRIME

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set
Primary Device ID00763000344511
NIH Device Record Key96630b1d-08e7-4a10-912f-87e6236a9c2b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCB6L58R2
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000344511 [Primary]

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 Date2020-01-06
Device Publish Date2019-12-29

Devices Manufactured by MEDTRONIC, INC.

00763000574598 - NA2025-02-18 COMMUNICATOR TM90T0 PROX US EMANUAL
00763000579388 - N/A2025-02-18 TELEMETRY MODULE TM90Q0 ISTIM X US
00763000879297 - NA2025-02-18 TELEMETRY TM90Q0 ISTIM X US EMAN
00763000988777 - NA2025-02-17 CUSTOM PACK BB6Z71R15 VA
20763000998145 - NA2025-02-17 CUSTOM PACK SSBB12N37R 10PK LOWER LMB
00763000998424 - NA2025-02-17 CUSTOM PACK BB10Z65R1 V A D
00763000517830 - Hancock™2025-02-14 CONDUIT HC15022 HK1 MO 26L
00763000995775 - NA2025-02-14 CUSTOM PACK BB11W65R2 SPECTRUM CPB

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