Instrument Command Library

GUDID 00763000378356

SW 2691 CARELINK INST COMMAND LIBRARY

MEDTRONIC, INC.

Implantable cardiac device management application software
Primary Device ID00763000378356
NIH Device Record Key5573bd18-6589-4120-ad62-6fc03c3c0c99
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstrument Command Library
Version Model Number2691
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
GS100763000378356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVZPulse generator, permanent, implantable

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.

20763000394091 - DxTerity™2025-01-28 DXT6JL45X DXT 6F 5PK 125CM JL45
20763000395180 - DxTerity™ TRA2025-01-28 CATH U5ULTRA35 DXT 5F 5PK 100CM UL35
00763000993924 - NA2025-01-28 CUSTOM PACK BB10Y59R12 FUSION
00763000993931 - NA2025-01-28 CUSTOM PACK BB7M46R26 SCV ADLT
00763000993948 - NA2025-01-28 CUSTOM PACK BB11U59R5 BYPASS TUBING
00763000993955 - NA2025-01-28 CUSTOM PACK BB8M65R3 RIDEOUT
08033477072012 - Pacific™ Plus2025-01-28 CATH PCP060300090 PLUS US D6L300UL900
08033477072029 - Pacific™ Plus2025-01-28 CATH PCP060300150 PLUS US D6L300UL1500

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