identifeye Camera System, reconditioned

GUDID 00850067214281

The identifeye Camera System is a fundus ophthalmic camera reconditioned.

Identifeye Health Inc.

Ophthalmic fundus camera
Primary Device ID00850067214281
NIH Device Record Key10d0d15f-bf75-4e43-b188-a931c1715b29
Commercial Distribution StatusIn Commercial Distribution
Brand Nameidentifeye Camera System, reconditioned
Version Model Number850-30004-00
Company DUNS117192383
Company NameIdentifeye Health Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (650) 505-5565
Emailsupport@identifeye.health
Phone+1 (650) 505-5565
Emailsupport@identifeye.health
Phone+1 (650) 505-5565
Emailsupport@identifeye.health
Phone+1 (650) 505-5565
Emailsupport@identifeye.health
Phone+1 (650) 505-5565
Emailsupport@identifeye.health
Phone+1 (650) 505-5565
Emailsupport@identifeye.health
Phone+1 (650) 505-5565
Emailsupport@identifeye.health
Phone+1 (650) 505-5565
Emailsupport@identifeye.health

Device Identifiers

Device Issuing AgencyDevice ID
GS100850067214281 [Primary]

FDA Product Code

PJZCamera, Ophthalmic, General-Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-15
Device Publish Date2025-07-07

Devices Manufactured by Identifeye Health Inc.

00850067214229 - identifeye Camera System, tablet2025-07-15 identifeye Camera System tablet accessory
00850067214236 - identifeye Camera System, power supply2025-07-15 identifeye Camera System power supply accessory
00850067214274 - identifeye Camera System2025-07-15 The identifeye Camera System is a fundus ophthalmic camera.
00850067214281 - identifeye Camera System, reconditioned2025-07-15The identifeye Camera System is a fundus ophthalmic camera reconditioned.
00850067214281 - identifeye Camera System, reconditioned2025-07-15 The identifeye Camera System is a fundus ophthalmic camera reconditioned.

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