VISION EX5

GUDID 00815871021753

DRE Vision EX5, DUAL CEILING

Avante

Medical monitor/light mount

• Primary Device ID: 00815871021753
• NIH Device Record Key: d625fbb2-91d2-46b5-b6e2-bcc09d1e4015
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISION EX5
• Version Model Number: DRE 061415
• Company DUNS: 178440426
• Company Name: Avante
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815871021753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140812

FDA Product Code

• FSY: Light, Surgical, Ceiling Mounted

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-19
• Device Publish Date: 2016-09-23

On-Brand Devices [VISION EX5]

• 00815871022453: DRE Vision EX5, FLOOR MODEL, BATTERY BACKUP
• 00815871022446: DRE Vision EX5, FLOOR MODEL, BATTERY BACKUP
• 00815871022316: DRE Vision EX5, DUAL CEILING
• 00815871022309: DRE Vision EX5, SINGLE CEILING
• 00815871022293: DRE Vision EX5, FLOOR MODEL
• 00815871022286: DRE Vision EX5, WALL MOUNT
• 00815871022279: DRE Vision EX5, DUAL CEILING
• 00815871022262: DRE Vision EX5, SINGLE CEILING
• 00815871022255: DRE Vision EX5, FLOOR MODEL
• 00815871022248: DRE Vision EX5, WALL MOUNT
• 00815871021791: DRE Vision EX5, DUAL CEILING
• 00815871021784: DRE Vision EX5, SINGLE CEILING
• 00815871021777: DRE Vision EX5, FLOOR MODEL
• 00815871021760: DRE Vision EX5, DUAL CEILING
• 00815871021753: DRE Vision EX5, DUAL CEILING
• 00815871021746: DRE Vision EX5, SINGLE CEILING
• 00815871021739: DRE Vision EX5, FLOOR MODEL
• 00815871021722: DRE Vision EX5, WALL MOUNT