Vivicon 700-53597-001

GUDID 00858848006445

Ophthalmic Camera

OPTOVUE, INC.

Ophthalmic fundus camera

• Primary Device ID: 00858848006445
• NIH Device Record Key: e36290ed-ce3d-428a-99fa-c934d2d9781c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivicon
• Version Model Number: Vivicon
• Catalog Number: 700-53597-001
• Company DUNS: 196500461
• Company Name: OPTOVUE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

Customer Support Contacts

• Phone: 866-941-9240
• Email: service@optovue.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858848006445 [Primary]

FDA Product Code

• PJZ: Camera, Ophthalmic, General-Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-08
• Device Publish Date: 2018-09-06

Devices Manufactured by OPTOVUE, INC.

• 00858848006766 - iFusion: 2020-09-01 iFusion 80 with 12 MP Camera
• 00858848006773 - iVue: 2020-09-01 iVue 80
• 00858848006780 - iCam: 2020-09-01 iCam 12 MP
• 00858848006735 - iScan: 2020-02-21 Ophthalmic Optical Coherence Tomography System
• 00858848006742 - iScan: 2020-02-21 Ophthalmic Optical Coherence Tomography System
• 00858848006728 - RTVue XR Avanti: 2020-02-11 Ophthalmic Optical Coherence Tomography System with 100/240V Table
• 00858848006704 - RTVue XR Avanti: 2019-09-30 Ophthalmic Optical Coherence Tomography System with 100/240V Table
• 00858848006667 - RTVue XR Avanti Scanner: 2019-06-20 For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System