OvuSense

GUDID 05060508530121

M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App

FERTILITY FOCUS LIMITED

Thermometric fertility analyser

• Primary Device ID: 05060508530121
• NIH Device Record Key: 054d6270-c508-44cf-94e5-4b91e5eb7a33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OvuSense
• Version Model Number: M400
• Company DUNS: 347449352
• Company Name: FERTILITY FOCUS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com
• Phone: +441926800502
• Email: support@ovusense.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060508530121 [Primary]

FDA Product Code

• LHD: Device, Fertility Diagnostic, Proceptive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-10
• Device Publish Date: 2021-05-01

On-Brand Devices [OvuSense]

• 05060508530039: M300 NFC OvuSense Starter Pack - OvuSense Personal Sensor M026, OvuSense App and M028 NFC Reader
• 05060508530121: M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App
• 05060508530091: M426 OvuFirst Skin Worn Sensor
• 05060508530114: OvuSense 2 App - Android
• 05060508530107: OvuSense 2 App - iOS