OvuSense

Basic Information

• Brand Name: OvuSense
• Primary DI: 05060508530039
• Version / Model: M300
• Company Name: VIO HEALTHTECH LIMITED
• Labeler DUNS: 347449352
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-11
• Public Version: 4
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: e0b6196e-7178-4c7f-abe9-fab219e6b9e7

Device Description

M300 OvuCore Starter Pack - M026 OvuCore Vaginal Sensor and M032 OvuSense App

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHD	Device, Fertility Diagnostic, Proceptive	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
36110	Thermometric fertility analyser	A hand-operated, battery-powered, electronic, instrument used for recording basal body temperature and cycle length to identify the fertile and infertile phases of the menstrual cycle. The device consists of a basal body temperature thermometer and a microprocessor programmed with a mathematical algorithm to calculate and identify temperature shifts. It is used to predict ovulation to optimize the chances for becoming pregnant or for determining safe periods where sexual intercourse may take place. It is typically a noninvasive, automatic device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060508530039	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]