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.

00199150005628 - NA2025-04-14 CUSTOM PACK BB12H36R7 PUMP TABLE
00199150005864 - NA2025-04-14 CUSTOM PACK BB11P84R2 FEM-AX
00199150005871 - NA2025-04-14 CUSTOM PACK BB10H16R9 PEDI
20199150005899 - NA2025-04-14 CUSTOM PACK BB4M03R3 2PK 3/8 VEN
00199150005901 - NA2025-04-14 CUSTOM PACK BB1W12R37 CV
20199150005943 - NA2025-04-14 CUSTOM PACK BB10N58R1 5PK HRTASSTPIGTAI
20199150005967 - NA2025-04-14 CUSTOM PACK BB6J29R1 5PK 3/8 VENOU
20199150006001 - NA2025-04-14 CUSTOM PACK 12N80R 5PK 1/4 SILASTIC TUB

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