BrainPort

Basic Information

• Brand Name: BrainPort
• Primary DI: 00862378000309
• Version / Model: V100
• Catalog Number: DR-001062
• Company Name: WICAB, INC
• Labeler DUNS: 158610712
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-11
• Public Version: 3
• Public Version Date: 2019-05-23
• Public Version Status: Update
• Public Device Record Key: eb0a042b-5ffc-4c6e-9b06-2c4cc0c15aa8

Device Description

The BrainPort® V100 is an oral electronic vision aid that provides electrotactile stimulation to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as the white cane or a guide dog. It translates digital information from a video camera to gentle electrical stimulation patterns on the surface of the tongue.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PIC	Oral Electronic Vision Aid	Ophthalmic	886.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62662	Video-camera translingual electrical stimulation system	An assembly of devices designed to assist a blind person in orientation, mobility, and object recognition by capturing video images and translating them into electrical stimuli which are applied to the tongue. It consists of a pair of dedicated video-camera spectacles, a controller, and an electrode array intended to be placed on the tongue. With training, the device is intended to enable users to interpret the shape, size, location and motion of objects in their environment as an adjunct to other assistive devices (e.g., guide dog, cane). This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00862378000309	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius