REMOTE ASSISTANT™

GUDID 00681490199285

SFTWR 9462 ACTVTR PATIENT REMOTE ASST

MEDTRONIC, INC.

Cardiac pulse generator test magnet
Primary Device ID00681490199285
NIH Device Record Keyf1b6c693-9416-4005-abbb-bdce74ecb498
Commercial Distribution Discontinuation2018-10-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameREMOTE ASSISTANT™
Version Model Number9462
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490199285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXYimplantable pacemaker Pulse-generator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-12
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00199150021055 - NA2025-06-06 CUSTOM PACK BB11B15R1 CHP CIRCUIT
00199150021062 - NA2025-06-06 CUSTOM PACK BB11F90R3 ADULT ECC3/8
00199150021079 - NA2025-06-06 CUSTOM PACK BB7C59R10 E C L S
20199150021110 - NA2025-06-06 CUSTOM PACK BB6X07R3 2PK 38 E
20199150021134 - NA2025-06-06 CUSTOM PACK BB12A97R1 5PK PIGTAIL
00199150021147 - NA2025-06-06 CUSTOM PACK BB10Z01R17 SUPPORT PACK
20199150021165 - NA2025-06-06 CUSTOM PACK BB10Y40R1 5PK BRIDGE PACK
20199150021653 - NA2025-06-06 CUSTOM PACK BB12D52R2 10PK 3/16 BRIDGE

Trademark Results [REMOTE ASSISTANT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REMOTE ASSISTANT
REMOTE ASSISTANT
77889781 3948759 Live/Registered
Carolina Ear & Hearing Clinic, PC
2009-12-09

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