VISION LED

GUDID 00815871021647

DRE Vision LED, WALL MOUNT

Avante

Medical monitor/light stand

• Primary Device ID: 00815871021647
• NIH Device Record Key: 7bd74431-77da-4a49-8cc6-0f972467b2ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISION LED
• Version Model Number: DRE 061512
• 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	00815871021647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100388

FDA Product Code

• FST: Light, Surgical, Fiberoptic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-23

On-Brand Devices [VISION LED]

• 00815871022439: DRE Vision LED, FLOOR MODEL, BATTERY BACKUP
• 00815871022422: DRE Vision LED, FLOOR MODEL, BATTERY BACKUP
• 00815871022231: DRE Vision LED, DUAL CEILING
• 00815871022224: DRE Vision LED, SINGLE CEILING
• 00815871022217: DRE Vision LED, FLOOR MODEL
• 00815871022200: DRE Vision LED, WALL MOUNT
• 00815871022194: DRE Vision LED, DUAL CEILING
• 00815871022187: DRE Vision LED, SINGLE CEILING
• 00815871022170: DRE Vision LED, FLOOR MODEL
• 00815871022163: DRE Vision LED, WALL MOUNT
• 00815871021678: DRE Vision LED, DUAL CEILING
• 00815871021661: DRE Vision LED, SINGLE CEILING
• 00815871021715: DRE Vision LED, DUAL CEILING
• 00815871021708: DRE Vision LED, SINGLE CEILING
• 00815871021692: DRE Vision LED, FLOOR MODEL
• 00815871021685: DRE Vision LED, WALL MOUNT
• 00815871021654: DRE Vision LED, FLOOR MODEL
• 00815871021647: DRE Vision LED, WALL MOUNT