VNS Therapy® Pulse Duo Model 102R Generator

GUDID 05425025750023

Implantable Pulse Generator

LIVANOVA USA, INC.

Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Primary Device ID05425025750023
NIH Device Record Key28ab844c-d967-40bb-8ef5-b1b29e5f7d58
Commercial Distribution StatusIn Commercial Distribution
Brand NameVNS Therapy® Pulse Duo Model 102R Generator
Version Model Number102R
Company DUNS194568978
Company NameLIVANOVA USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cyberonics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105425025750023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUZStimulator, Autonomic Nerve, Implanted (Depression)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2014-09-17

Devices Manufactured by LIVANOVA USA, INC.

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00803622156281 - Perfusion Pack2024-03-26
00803622156304 - Perfusion Pack2024-03-26

Trademark Results [VNS Therapy]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VNS THERAPY
VNS THERAPY
78939216 3607760 Live/Registered
LIVANOVA USA, INC.
2006-07-27
VNS THERAPY
VNS THERAPY
78939212 3607759 Dead/Cancelled
LIVANOVA USA, INC.
2006-07-27

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