| Primary Device ID | B675DC0 |
| NIH Device Record Key | fec22173-67fd-46e3-9d42-047dd573549d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zeto ONE Disinfection Container with Lid |
| Version Model Number | ZP-301-10001 |
| Company DUNS | 079582566 |
| Company Name | ZETO INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| B675DC0 - Zeto ONE Disinfection Container with Lid | 2024-11-28The Zeto ONE Disinfection Container with Lid is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns.
The Disinfection Container is plastic bowl with a special geometry and a purpose built lid. It is intended to hold the Zeto ONE headset in a disinfecting liquid for reprocessing. |
| B675DC0 - Zeto ONE Disinfection Container with Lid | 2024-11-28 The Zeto ONE Disinfection Container with Lid is an accessory of the Zeto ONE, which is an EEG system intended for prescription u |
| B675MM0 - Zeto All-in-One Medical Grade PC | 2024-11-28 The "Zeto All-in-One Medical Grade PC" is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in |
| B675ONEAUX1 - Zeto ONE AUX Cable Extension Set | 2024-06-19 The Zeto ONE AUX Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in he |
| B675ONEDU0 - Zeto ONE Display Unit | 2024-06-19 The Zeto ONE Display Unit (DU) is a part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare fac |
| B675ONEECG1 - Zeto ONE ECG Cable Extension Set | 2024-06-19 The Zeto ONE ECG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in he |
| B675ONEEMG1 - Zeto ONE EMG Cable Extension Set | 2024-06-19 The Zeto ONE EMG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in he |
| B675ONEESB1 - Zeto ONE Electrode Set — Basic | 2024-06-19 The Zeto ONE Electrode Set — Basic is a part of the Zeto ONE, which is an EEG system intended for prescription use in a health |
| B675ONEHEOG1 - Zeto ONE HEOG Cable Extension Set | 2024-06-19 The Zeto ONE HEOG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in h |