Primary Device ID | 00850067214281 |
NIH Device Record Key | 10d0d15f-bf75-4e43-b188-a931c1715b29 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | identifeye Camera System, reconditioned |
Version Model Number | 850-30004-00 |
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 | 00850067214281 [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 | 2025-07-15 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 | 2025-07-15The identifeye Camera System is a fundus ophthalmic camera reconditioned. |
00850067214281 - identifeye Camera System, reconditioned | 2025-07-15 The identifeye Camera System is a fundus ophthalmic camera reconditioned. |