Paired VNS

Primary DI
10810041430141
Brand
Paired VNS
Company
Microtransponder
Model
2100
Device description
Wireless Transmitter
Published
2022-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
QPYStimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPYStimulator, Autonomic Nerve, Implanted For Stroke RehabilitationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P210007001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210007001Vivistim® SystemMobia Medical, Inc.2021-08-27QPY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041430141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081004143014110810041430141

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793502068
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810041430158MicroTransponder60012024-08-06
10810041430028Vivistim® 10012022-04-29
10810041430066Paired VNS30002022-04-29
10810041430080Paired VNS30002022-04-29
10810041430004Vivistim40012022-03-28
10810041430042Paired VNS20002022-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810041430028Vivistim® MicrotransponderQPY2022-04-29
10810041430066Paired VNSMicrotransponderQPY2022-04-29
10810041430080Paired VNSMicrotransponderQPY2022-04-29
10810041430004VivistimMicrotransponderQPY2022-03-28
10810041430042Paired VNSMicrotransponderQPY2022-03-28