AccessGUDID - DEVICE: ovul (00860012674701)

GUDID

Device Identifier (DI) Information

Brand Name: ovul
Version or Model: 2.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1001
Company Name: Ovulio Corp.

Primary DI Number: 00860012674701
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119226698 *Terms of Use

Device Description: Saliva fertility tracker

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:	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?
61073	Personal ovulation microscope IVD	A non-sterile, hand-held eyepiece with a magnifying lens intended to be used for the visualization of crystallised patterns in a female’s saliva sample, which may identify the days of ovulation i.e., the most fertile days in the menstrual cycle, as an aid for natural conception. It is available [non-prescription] over-the-counter (OTC) for home-use and is not intended to be used as a form of contraception. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGE	Test, Luteinizing Hormone (Lh), Over The Counter

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 29a0e763-157c-4aea-a76e-ad01b4de67e5
Public Version Date: September 09, 2024
Public Version Number: 1
DI Record Publish Date: August 30, 2024

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1-763-341-4692
Email: info@ovul.ai

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