OvuSense

GUDID 05060508530121

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

FERTILITY FOCUS LIMITED

Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser Thermometric fertility analyser 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