OvuSense

GUDID 05060508530114

OvuSense 2 App - Android

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

• Primary Device ID: 05060508530114
• NIH Device Record Key: 022032b2-620c-4600-bba1-a12fad54eb75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OvuSense
• Version Model Number: M032 Android
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060508530114 [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: 2021-08-02
• Device Publish Date: 2021-07-23

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