GUDID 00613994500793

PRGMR 37651FA ACTIVA INSR FIXED ASSET

MEDTRONIC, INC.

Noninvasive device battery charger
Primary Device ID00613994500793
NIH Device Record Key4cdc9cd4-dd02-43eb-a296-937e096f05f5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number37651FA
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
GS100613994500793 [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.

20199150061970 - NA2025-12-08 CUSTOM PACK BB12R02R3 5PK ACC STRNG SUC
00199150062027 - NA2025-12-08 CUSTOM PACK BB12R85R AVL 3/8 ECCPK
20199150062229 - NA2025-12-08 CUSTOM PACK BB1Q47R3 5PK ACC TABLE
20199150062243 - NA2025-12-08 CUSTOM PACK BB12R66R 20PK ACC 1/4 W/LL
20199150062960 - NA2025-12-08 CUSTOM PACK BB9R13R15 4PK CPN PLEG PACK
00643169265691 - NA2025-12-08 LEAD ACC KIT 6056M GLOBAL 17L NEW ACI
00199150060467 - NA2025-11-28 CUSTOM PACK BB11Q49R14 EVL 3/8 EC
00199150060627 - NA2025-11-28 CUSTOM PACK BB12M28R9 HLO QHLM-FROS

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