| Primary Device ID | 05060508530053 | 
| NIH Device Record Key | c60b014e-3f16-4506-8222-75ee48c26a61 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | OvuSense NFC Sensor | 
| Version Model Number | M026 | 
| 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 | true | 
| 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 | 
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | |
| Phone | +441926400054 | 
| support@ovusense.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05060508530053 [Primary] | 
| LHD | Device, Fertility Diagnostic, Proceptive | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2017-12-11 | 
| 05060508530107 - OvuSense | 2021-08-02 OvuSense 2 App - iOS | 
| 05060508530114 - OvuSense | 2021-08-02 OvuSense 2 App - Android | 
| 05060508530091 - OvuSense | 2021-05-10 M426 OvuFirst Skin Worn Sensor | 
| 05060508530121 - OvuSense | 2021-05-10 M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App | 
| 05060508530046 - FertiloScope | 2020-01-09 Transvaginal Cannula with its pointed trocar, devised for introduction in the pouch of Douglas in order to perform a Transvagina | 
| 05060508530039 - OvuSense | 2018-03-29 M300 NFC OvuSense Starter Pack - OvuSense Personal Sensor M026, OvuSense App and M028 NFC Reader | 
| 05060508530053 - OvuSense NFC Sensor | 2018-03-29M026 OvuSense NFC Sensor | 
| 05060508530053 - OvuSense NFC Sensor | 2018-03-29 M026 OvuSense NFC Sensor |