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.

20763000982946 - NA2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD
00763000984007 - NA2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG
00763000984021 - NA2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE
00763000984151 - NA2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT
00763000984168 - NA2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS
00763000984175 - NA2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK
00763000180010 - Sprint Quattro Secure S™2024-11-12 LEAD 693552 SPRINT US RCMCRD
00763000180027 - Sprint Quattro Secure S™2024-11-12 LEAD 693575 SPRINT US RCMCRD

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.