VNS Therapy® Programmer, Model 3000 v1.0

GUDID 05425025750399

Programmer

LIVANOVA USA, INC.

Vagus nerve electrical stimulation system programmer
Primary Device ID05425025750399
NIH Device Record Key6ffa77dc-dd0c-4cb8-b487-b29639d0d044
Commercial Distribution StatusIn Commercial Distribution
Brand NameVNS Therapy® Programmer, Model 3000 v1.0
Version Model Number3000
Company DUNS194568978
Company NameLIVANOVA USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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@liva

Operating and Storage Conditions

Storage Environment TemperatureBetween -22 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105425025750399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUZStimulator, Autonomic Nerve, Implanted (Depression)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-06

Devices Manufactured by LIVANOVA USA, INC.

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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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