Device Command Library

GUDID 00763000378363

SW 2692 CARELINK DEVICE COMMAND LIBRARY

MEDTRONIC, INC.

Implantable cardiac device management application software
Primary Device ID00763000378363
NIH Device Record Key12717fe0-f6ab-4591-96d6-f653757cc7f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDevice Command Library
Version Model Number2692
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 Kitfalse
Device Combination Productfalse
Single Usefalse
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000378363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSRPacemaker/icd/crt non-implanted components

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-13
Device Publish Date2024-05-04

Devices Manufactured by MEDTRONIC, INC.

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20199150000320 - NA2025-03-14 CUSTOM PACK BB10V15R5 5PK SUPP
20199150000344 - NA2025-03-14 CUSTOM PACK BB8S27R1 5PK Y LINE CB
20199150000368 - NA2025-03-14 CUSTOM PACK BB11P52R1 5PK Y LINE CB
00199150000616 - NA2025-03-14 CUSTOM PACK BB11N74R15 CCS-ST MARKS
00199150000623 - NA2025-03-14 CUSTOM PACK BB7E57R18 PUMP
00199150000630 - NA2025-03-14 CUSTOM PACK BB11B96R4 HEART PACK

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