GUDID 00763000959760

CUSTOM PACK BB10L08R6 LYFLAT PK

MEDTRONIC, INC.

Cardiopulmonary bypass system blood tubing set
Primary Device ID00763000959760
NIH Device Record Keyf702ea81-3740-4be6-9af1-ba5c905e5611
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBB10L08R6
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000959760 [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 Date2024-07-05
Device Publish Date2024-06-27

Devices Manufactured by MEDTRONIC, INC.

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00763000879280 - Verify™2024-07-05 ENS 353101 VERIFY ISTM US REFURB EMAN
00763000959050 - NA2024-07-05 CUSTOM PACK BB11B31R7 CCS SUPP PK
00763000959609 - NA2024-07-05 CUSTOM PACK BB10E56R15 COMBO
00763000959760 - NA2024-07-05CUSTOM PACK BB10L08R6 LYFLAT PK
00763000959760 - NA2024-07-05 CUSTOM PACK BB10L08R6 LYFLAT PK
00763000959821 - NA2024-07-05 CUSTOM PACK BB11U53R1 E HEART L
00763000959838 - NA2024-07-05 CUSTOM PACK BB11Q22R7 LOURDES SUP P
00763000959845 - NA2024-07-05 CUSTOM PACK 12G61R1 NURSES

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