| Primary Device ID | 00850067214236 |
| NIH Device Record Key | 90afed55-4d6c-4e48-9d6f-d44e7c3121ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | identifeye Camera System, power supply |
| Version Model Number | 815-30020-00 |
| Company DUNS | 117192383 |
| Company Name | Identifeye Health Inc. |
| 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 |
| Phone | +1 (650) 505-5565 |
| support@identifeye.health | |
| Phone | +1 (650) 505-5565 |
| support@identifeye.health | |
| Phone | +1 (650) 505-5565 |
| support@identifeye.health | |
| Phone | +1 (650) 505-5565 |
| support@identifeye.health | |
| Phone | +1 (650) 505-5565 |
| support@identifeye.health | |
| Phone | +1 (650) 505-5565 |
| support@identifeye.health | |
| Phone | +1 (650) 505-5565 |
| support@identifeye.health | |
| Phone | +1 (650) 505-5565 |
| support@identifeye.health |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850067214236 [Primary] |
| PJZ | Camera, Ophthalmic, General-Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-15 |
| Device Publish Date | 2025-07-07 |
| 00850067214229 - identifeye Camera System, tablet | 2025-07-15 identifeye Camera System tablet accessory |
| 00850067214236 - identifeye Camera System, power supply | 2025-07-15identifeye Camera System power supply accessory |
| 00850067214236 - identifeye Camera System, power supply | 2025-07-15 identifeye Camera System power supply accessory |
| 00850067214274 - identifeye Camera System | 2025-07-15 The identifeye Camera System is a fundus ophthalmic camera. |
| 00850067214281 - identifeye Camera System, reconditioned | 2025-07-15 The identifeye Camera System is a fundus ophthalmic camera reconditioned. |