GUDID 00643169518988

CHARGING SYS 37651 ACTIVA INSR USA ROHS

MEDTRONIC, INC.

Noninvasive device battery charger
Primary Device ID00643169518988
NIH Device Record Key6edde394-502f-40fb-b708-b010c3103379
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
GS100643169518988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHYSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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 Date2014-12-22

Devices Manufactured by MEDTRONIC, INC.

00763000963705 - NA2024-08-05 CUSTOM PACK BB11W58R3 BAP SOUTH E C
00763000964061 - NA2024-08-05 CUSTOM PACK BB12H45R ST BERNARDS SU
20763000963723 - NA2024-08-02 CUSTOM PACK 12F80R1 10PK 3/8 PLUG
00763000963736 - NA2024-08-02 CUSTOM PACK CB5D50R5 3/8 A-V
20763000963754 - NA2024-08-02 CUSTOM PACK 12H75R 10PK GUARDIA TUBING G
00763000963781 - NA2024-08-02 CUSTOM PACK BB7L12R8 ADULT E
00763000926465 - Hancock™ 1502024-07-30 HANCOCK VALVED CONDUIT MO 12MM
00763000926472 - Hancock™ 1502024-07-30 HANCOCK VALVED CONDUIT MO 14MM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.