iVue 700-48577-004

GUDID 00858848006094

iVue NR Complete System USCFG w/ 230V Table

OPTOVUE, INC.

Spectral-domain optical coherence tomography system

• Primary Device ID: 00858848006094
• NIH Device Record Key: a202657f-c5ad-40d0-842a-9ed6a0421e0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iVue
• Version Model Number: iVue 100-2
• Catalog Number: 700-48577-004
• 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	00858848006094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121739

FDA Product Code

• HLI: Ophthalmoscope, Ac-Powered

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 [iVue]

• 00858848006612: iVue NR Complete System w/ 120V Table
• 00858848006605: iVue NR Complete System USCFG w/ 120V Table
• 00858848006568: iVue NR Complete System USCFG w/ 230V Table
• 00858848006551: iVue NR Complete System w/ 230V Table
• 00858848006544: iVue NR System w/o Laptop 120V
• 00858848006537: iVue NR System w/o Laptop USCFG 120V
• 00858848006506: iVue NR System w/o Laptop 230V
• 00858848006490: iVue NR System w/o Laptop USCFG 230V
• 00858848006483: iVue NR Complete System iWellness USCFG w/ 120V Table
• 00858848006476: Assy Scanner iVue NR
• 00858848006223: Assy Scanner iVue NR
• 00858848006216: iVue NR Complete System iWellness USCFG w/ 120V Table
• 00858848006162: iVue NR System w/o Laptop USCFG 230V
• 00858848006155: iVue NR System w/o Laptop 230V
• 00858848006148: iVue NR System w/ Laptop USCFG 230V
• 00858848006131: iVue NR System w/ Laptop 230V
• 00858848006124: iVue NR System w/o Laptop USCFG 120V
• 00858848006117: iVue NR System w/o Laptop 120V
• 00858848006100: iVue NR Complete System w/ 230V Table
• 00858848006094: iVue NR Complete System USCFG w/ 230V Table
• 00858848006087: iVue NR System iWellness w/ Laptop USCFG 120V
• 00858848006070: iVue NR System USCFG w/ Laptop 120V
• 00858848006063: iVue NR System w/ Laptop 120V
• 00858848006056: iVue NR Complete System USCFG w/ 120V Table
• 00858848006049: iVue NR Complete System w/ 120V Table
• 00858848006773: iVue 80