GUDID 00763000059477

SERVICE KIT 5873C OUS US EIFU

MEDTRONIC, INC.

Pacing/defibrillation lead repair kit
Primary Device ID00763000059477
NIH Device Record Keyb854e4bd-82bc-4f96-9091-a1edc6871c4a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5873C
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 Kittrue
Device Combination Productfalse
Single Usetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000059477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSRPacemaker/icd/crt non-implanted components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-28
Device Publish Date2018-12-28

Devices Manufactured by MEDTRONIC, INC.

20199150045680 - NA2025-09-22 CUSTOM PACK BB12R79R 10PK EVL COA 3/8 TU
00199150045693 - NA2025-09-22 CUSTOM PACK BB12R38R EVL 1/4ECC
00199150045808 - NA2025-09-22 CUSTOM PACK BB12F62R4 HLO UOF HE PA
00199150045815 - NA2025-09-22 CUSTOM PACK BB10B09R2 EVL EC SUP PK
00199150045822 - NA2025-09-22 CUSTOM PACK BB2S09R29 CV PACK
00199150045839 - NA2025-09-22 CUSTOM PACK BB12J21R6 EVL ADULT EC
00199150045860 - NA2025-09-22 CUSTOM PACK BB10B53R7 ADULT SUPPORT
00199150046010 - NA2025-09-22 CUSTOM PACK BB5G56R17 PUMP TBL

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