GUDID 00613994852731

PRGM 37651 DBS ACTIVA RC W/UPDATES US

MEDTRONIC, INC.

Noninvasive device battery charger
Primary Device ID00613994852731
NIH Device Record Keyd8728339-09e3-4869-9770-12dd9ce8b8d6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number37651
Company DUNS796986144
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 Batchfalse
Serial Numbertrue
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 -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994852731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHLSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

20199150041118 - NA2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE
20199150041132 - NA2025-08-18 CUSTOM PACK BB5G89R2 2PK T SPRT
00763000876982 - SPRINTER® LEGEND2025-08-18 BALLOON SPL12506X SPR LEG RX US M
00763000876999 - SPRINTER® LEGEND2025-08-18 BALLOON SPL12510X SPR LEG RX US M
00763000877002 - SPRINTER® LEGEND2025-08-18 BALLOON SPL12512X SPR LEG RX US M
00763000877019 - SPRINTER® LEGEND2025-08-18 BALLOON SPL12515X SPR LEG RX US M
00763000877026 - SPRINTER® LEGEND2025-08-18 BALLOON SPL12520X SPR LEG RX US M
00763000925079 - FlexCath Cross™ Transseptal Solution2025-08-18 NDL 900300 FLEXCATH CROSS AG 61CM EIFU

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