Vivistim

Primary DI
10810041430004
Brand
Vivistim
Company
Microtransponder
Model
4001
Device description
Stroke Application and Programming Software
Published
2022-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
P210007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210007000Vivistim® SystemMobia Medical, Inc.2021-08-27QPY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041430004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081004143000410810041430004

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793502068
Device count
1
Lot or batch
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
10810041430042Paired VNS20002022-03-28
10810041430141Paired VNS21002022-03-28

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
10810041430042Paired VNSMicrotransponderQPY2022-03-28
10810041430141Paired VNSMicrotransponderQPY2022-03-28