GUDID 00681490501880

SFTWR 9790XLA LEAD PATIENT LONG 9790 TAC

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use
Primary Device ID00681490501880
NIH Device Record Key8ad4368e-a2f0-488d-b3c6-fa6e0b4a2163
Commercial Distribution Discontinuation2019-01-25
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number9790XLA
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 Producttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490501880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRGProgrammer, pacemaker

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-18
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00199150033478 - NA2026-03-10 RECHARGE SYSTEM RS7230 US INCEPTIV
20199150071313 - NA2026-03-10 CUSTOM PACK BB12Q91R 5PK ACC 1/4 INC
20199150071337 - NA2026-03-10 CUSTOM PACK BB12T57R 5PK ACC BARNES DPC
20199150071641 - NA2026-03-10 CUSTOM PACK BB12T16R1 2PK AVL ENDEAVOR
20199150071665 - NA2026-03-10 CUSTOM PACK BB12S13R1 5PK AVL 3/8
00199150071678 - NA2026-03-10 CUSTOM PACK BB5G80R37 E. 1/4 PK
20199150071832 - NA2026-03-10 CUSTOM PACK BB12T25R 5PK ACC COATED COM
00199150071845 - NA2026-03-10 CUSTOM PACK BB12B01R5 EVL PEDS C

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.