AccessGUDID - DEVICE: YO Home Sperm Test (07290012140983)

GUDID

Device Identifier (DI) Information

Brand Name: YO Home Sperm Test
Version or Model: For I-Phone 5/5S/SE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

Primary DI Number: 07290012140983
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514680529 *Terms of Use

Device Description: No description.

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):	Yes
Kit:	Yes
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?
61920	Motile sperm concentration IVD, kit, imaging, self-testing	A collection of devices intended to be used to visualize sperm and calculate motile sperm concentration in a semen specimen for the assessment of male fertility. It includes a magnifying lens and application software. The lens is intended to be attached to a compatible mobile communication device with a camera (not included) which runs the software to enable visualization and analysis of sperm in the semen specimen. It also includes materials to collect, process, and display the semen specimen. It is available [non-prescription] over-the-counter (OTC) for use in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
POV	Semen Analysis Device

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd35d1f4-0afe-4af1-b650-36db130b311b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 22, 2017