| Primary Device ID | 17290019239021 |
| NIH Device Record Key | 12a07548-d03b-47bd-91d9-3badbc06e0c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FIZE kUO Console |
| Version Model Number | 2.4G2 |
| Catalog Number | FI-FG00-KU00-0005 |
| Company DUNS | 649273943 |
| Company Name | FIZE RESEARCH LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290019239024 [Primary] |
| GS1 | 17290019239021 [Package] Contains: 07290019239024 Package: with power box [1 Units] In Commercial Distribution |
| GS1 | 27290019239028 [Package] Contains: 07290019239024 Package: with power supply [1 Units] In Commercial Distribution |
| EXY | Uroflowmeter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-07 |
| Device Publish Date | 2025-04-29 |
| 07290019239000 | FI-FGUS-KU00-0001 |
| 07290019239277 | FIZE kUO Console 2.4G |
| 17290019239038 | FIZE kUO Console 5G catalog number: FI-FG00-KU00-0006 FIZE kUO console 5G with power box US cata |
| 17290019239021 | FIZE kUO Console 2.4G catalog number: FI-FG00-KU00-0005 FIZE kUO Console 2.4G with power box US |
| 17290019239014 | FIZE kUO Console 5G |