AccessGUDID - DEVICE: Dynavision (00860011067627)

GUDID

Device Identifier (DI) Information

Brand Name: Dynavision
Version or Model: D2 110v with Mobile Stand
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynavision Global Holdings, LLC

Primary DI Number: 00860011067627
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079220528 *Terms of Use

Device Description: Attention Task Performance Recorder

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
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?
67212	Reaction trainer	An electrically-powered device intended to assess and train sensory-motor integration (e.g., visual reaction time, eye-hand coordination) and peripheral awareness for the purposes of neurorehabilitation as well as athletic and military performance improvement. It is in the form of an upright board (e.g., touchscreen) with a number of light-up buttons; the user is instructed to focus on the screen and press the buttons as they are illuminated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQD	Recorder, Attention Task Performance

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K911938	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d2be3c20-d9ca-4ae3-b3d6-dc4f273ee3f2
Public Version Date: June 18, 2024
Public Version Number: 1
DI Record Publish Date: June 10, 2024