FDA.reportPublic FDA data

Brevio

Primary DI
B1870223
Brand
Brevio
Company
NEUROTRON MEDICAL, INC.
Model
BRV-0250
Device description
Neuro-sensor, 5 pouches/box
Published
2016-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JXEDevice, Nerve Conduction Velocity Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXEDevice, Nerve Conduction Velocity MeasurementNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012069000MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENTNeurotron Medical, Inc.2001-08-01JXE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1870223PrimaryHIBCC0
B1870220Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic peripheral nerve electrical stimulation systemAn assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
147018519
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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B1870830PDC RestorerPLB066-02162024-12-04
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B1870470PDC RestorerPLB066-10802024-10-14
B1870790PDC RestorerPLB066-20302024-10-14
B1870781PDC RestorerPLB066-30502023-11-03
B1870780PDC RestorerPLB066-30502023-11-03
B1870770PDC RestorerPLB066-3024C2023-07-20
B1870760PDC RestorerPLB066-3021C2023-05-10
B1870750Relief MedicalPLB043-30162023-03-17
B1870740PDC RestorerPLB066-3022C2023-02-27
B1870080TheraKnitTKG-30242020-06-26
B1870010TheraKnitTKG-30152018-03-27
B1870020TheraKnitTKG-30162017-11-28
B1870050TheraKnitTKG-30192017-05-30

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Primary DI, Brand, Company table
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