VNS Therapy® Model 250 v11.0 Programming Software

GUDID 05425025750368

Programming Software

LIVANOVA USA, INC.

Vagus nerve electrical stimulation system programmer
Primary Device ID05425025750368
NIH Device Record Key593bfcd4-dec1-4cb1-991b-86204ef664ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameVNS Therapy® Model 250 v11.0 Programming Software
Version Model Number250 v11.0
Company DUNS194568978
Company NameLIVANOVA USA, 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 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@cybe

Operating and Storage Conditions

Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105425025750368 [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 Date2015-06-02

On-Brand Devices [VNS Therapy® Model 250 v11.0 Programming Software]

05425025750375Programming Software
05425025750368Programming Software

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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