AccessGUDID - DEVICE: OculoMotor Technologies (00860012940608)

GUDID

Device Identifier (DI) Information

Brand Name: OculoMotor Technologies
Version or Model: VERVE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Oculomotor Technologies Inc.

Primary DI Number: 00860012940608
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081121764 *Terms of Use

Device Description: Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy

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):	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?
66912	Virtual-display routine exercise software	A software package intended to be used on a non-medical computerized device and a display unit (e.g., television) to provide virtual exercise-based interactive activities/games for daily/regular use to help maintain or improve physical/mental health. It may be intended for use with one or more type(s) of electronic exercise device(s) [e.g., cycle device] and may provide one or more type(s) of on-screen interaction (e.g., video of a journey). It is not intended to provide specific biomechanical function analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SBN	Digital Therapy Device For Convergence Insufficiency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232930	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: 2a92118f-2bda-4936-b651-a84e9b6ce1fa
Public Version Date: February 05, 2025
Public Version Number: 1
DI Record Publish Date: January 28, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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