| 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 |