iFusion 700-49002-004

GUDID 00858848006193

iVue NR for iFusion 230V

OPTOVUE, INC.

Ophthalmic fundus camera

• Primary Device ID: 00858848006193
• NIH Device Record Key: 82d7318d-69db-4e7a-9686-948c752b6cf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFusion
• Version Model Number: iFusion
• Catalog Number: 700-49002-004
• Company DUNS: 196500461
• Company Name: OPTOVUE, 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: 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	00858848006193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130656

FDA Product Code

• OBO: Tomography, Optical Coherence

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [iFusion]

• 00858848006650: iVue NR for iFusion USCFG 230V
• 00858848006643: iVue NR for iFusion 230V
• 00858848006636: iVue NR for iFusion USCFG 120V
• 00858848006629: iVue NR for iFusion 120V
• 00858848006308: iVue NR for iFusion USCFG System w/ 230V Table
• 00858848006292: iVue NR for iFusion System w/ 230V Table
• 00858848006247: iVue NR for iFusion USCFG System w/ 120V Table
• 00858848006230: iVue NR for iFusion System w/ 120V Table
• 00858848006209: iVue NR for iFusion USCFG 230V
• 00858848006193: iVue NR for iFusion 230V
• 00858848006186: iVue NR for iFusion USCFG 120V
• 00858848006179: iVue NR for iFusion 120V
• 00858848006766: iFusion 80 with 12 MP Camera