VNS Therapy® Pulse Duo Model 102R Generator

Primary DI
05425025750023
Brand
VNS Therapy® Pulse Duo Model 102R Generator
Company
LIVANOVA USA, INC.
Model
102R
Device description
Implantable Pulse Generator
Published
2014-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
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
P970003047
P970003158

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970003047VNS THERAPY SYSTEMLivaNova USA, Inc.1997-07-16LYJ
P970003158VNS THERAPY SYSTEMLivaNova USA, Inc.1997-07-16LYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425025750023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425025750023054250257500235425025750023

GMDN Terms#

Term, Definition table
TermDefinition
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation systemAn assembly of battery-powered devices intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). The vagus nerve stimulation (VNS) is provided through an implantable pulse generator, typically placed in the anterior chest wall, and leads that run subcutaneously to where their electrodes are implanted around the left vagus nerve. The system may be programmed externally following implantation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
194568978
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration 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
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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
05425025750177VNS Therapy® Programming Wand Model 2000LIVANOVA USA, INC.MUZ2017-10-06
05425025750177VNS Therapy® Programming Wand Model 2000LIVANOVA USA, INC.LYJ2017-10-06
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
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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
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05425025750016VNS Therapy® Pulse Model 102 GeneratorLIVANOVA USA, INC.MUZ2014-09-17
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