VNS Therapy® Programming Wand Model 2000

Primary DI
05425025750177
Brand
VNS Therapy® Programming Wand Model 2000
Company
LIVANOVA USA, INC.
Model
2000
Device description
Programming Wand
Published
2017-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYJStimulator, Autonomic Nerve, Implanted For Epilepsy
MUZStimulator, Autonomic Nerve, Implanted (Depression)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYJStimulator, Autonomic Nerve, Implanted For EpilepsyUnknown3
MUZStimulator, Autonomic Nerve, Implanted (Depression)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970003210

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970003210VNS THERAPY SYSTEMLivaNova USA, Inc.1997-07-16LYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425025750177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425025750177054250257501775425025750177

GMDN Terms#

Term, Definition table
TermDefinition
Vagus nerve electrical stimulation system programmerA device intended to be used to change, noninvasively, one or more of the operating parameters (the programs) of an implanted stimulator used for vagus nerve stimulation (VNS). It is able to read stored parameters in the implanted device, providing historic and/or current information regarding device performance. The device is typically an electronic wand with a communication antenna that connects to the port of a personal computer (PC) with dedicated software. The PC will then drive the electronics of the wand to communicate with the implanted stimulation system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-22 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (866) 882-8804ClinicalTechnicalServices@liva
1 (866) 882-8804ClinicalTechnicalServices@livanova.com

Regulatory Flags#

DUNS number
194568978
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05425025750634VNS Therapy™ Programmer, Model 3100 v1.1.0LIVANOVA USA, INC.LYJ2023-09-19
05425025750535VNS Therapy® Programmer, Model 3000 v1.6.2 LIVANOVA USA, INC.LYJ2021-03-01
05425025750535VNS Therapy® Programmer, Model 3000 v1.6.2 LIVANOVA USA, INC.MUZ2021-03-01
05425025750528VNS Therapy® SenTiva Duo™ Model 1000-D GeneratorLIVANOVA USA, INC.MUZ2020-07-22
05425025750528VNS Therapy® SenTiva Duo™ Model 1000-D GeneratorLIVANOVA USA, INC.LYJ2020-07-22
05425025750511Symmetry™ VNS Therapy Kit Model 98142LIVANOVA USA, INC.MUZ2020-03-23
05425025750443VNS Therapy® Programmer, Model 3000 v1.6 LIVANOVA USA, INC.LYJ2019-09-09
05425025750443VNS Therapy® Programmer, Model 3000 v1.6 LIVANOVA USA, INC.MUZ2019-09-09
05425025750504VNS Therapy® Symmetry™ Model 8103 GeneratorLIVANOVA USA, INC.MUZ2019-09-09
05425025750429VNS Therapy® Programmer, Model 3000 v1.5 LIVANOVA USA, INC.MUZ2018-08-01
05425025750429VNS Therapy® Programmer, Model 3000 v1.5 LIVANOVA USA, INC.LYJ2018-08-01
05425025750481VNS Therapy® Programmer, Model 3000 v1.0.2 LIVANOVA USA, INC.LYJ2018-02-16
05425025750481VNS Therapy® Programmer, Model 3000 v1.0.2 LIVANOVA USA, INC.MUZ2018-02-16
05425025750399VNS Therapy® Programmer, Model 3000 v1.0 LIVANOVA USA, INC.LYJ2017-10-06
05425025750399VNS Therapy® Programmer, Model 3000 v1.0 LIVANOVA USA, INC.MUZ2017-10-06
05425025750405VNS Therapy® SenTiva™ Model 1000 GeneratorLIVANOVA USA, INC.MUZ2017-10-06
05425025750405VNS Therapy® SenTiva™ Model 1000 GeneratorLIVANOVA USA, INC.LYJ2017-10-06
05425025750375VNS Therapy® Model 250 v11.0 Programming SoftwareLIVANOVA USA, INC.MUZ2015-10-29
05425025750375VNS Therapy® Model 250 v11.0 Programming SoftwareLIVANOVA USA, INC.LYJ2015-10-29
05425025750061VNS Therapy® AspireSR® Model 106 GeneratorLIVANOVA USA, INC.LYJ2015-06-02
05425025750368VNS Therapy® Model 250 v11.0 Programming SoftwareLIVANOVA USA, INC.LYJ2015-06-02
05425025750368VNS Therapy® Model 250 v11.0 Programming SoftwareLIVANOVA USA, INC.MUZ2015-06-02
05425025750382VNS Therapy® Model 250 v10.0 Programming SoftwareLIVANOVA USA, INC.MUZ2015-04-01
05425025750382VNS Therapy® Model 250 v10.0 Programming SoftwareLIVANOVA USA, INC.LYJ2015-04-01
05425025750016VNS Therapy® Pulse Model 102 GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750016VNS Therapy® Pulse Model 102 GeneratorLIVANOVA USA, INC.MUZ2014-09-17
05425025750023VNS Therapy® Pulse Duo Model 102R GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750023VNS Therapy® Pulse Duo Model 102R GeneratorLIVANOVA USA, INC.MUZ2014-09-17
05425025750030VNS Therapy® Demipulse® Model 103 GeneratorLIVANOVA USA, INC.MUZ2014-09-17
05425025750030VNS Therapy® Demipulse® Model 103 GeneratorLIVANOVA USA, INC.LYJ2014-09-17