AccessGUDID - DEVICE: BrainPort (00862378000309)

GUDID

Device Identifier (DI) Information

Brand Name: BrainPort
Version or Model: V100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DR-001062
Company Name: WICAB, INC

Primary DI Number: 00862378000309
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 158610712 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIC	Oral Electronic Vision Aid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb0a042b-5ffc-4c6e-9b06-2c4cc0c15aa8
Public Version Date: May 23, 2019
Public Version Number: 3
DI Record Publish Date: August 11, 2017