LUMIN

GUDID 04719896530077

21.3" 3MP Color LCD Medical Display

ACULA TECHNOLOGY CORPORATION

Image display unit, colour

• Primary Device ID: 04719896530077
• NIH Device Record Key: afb2235b-4aa9-453d-95e5-bc816ecbff3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMIN
• Version Model Number: UMD3-21B01
• Company DUNS: 656742004
• Company Name: ACULA TECHNOLOGY CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719896530077 [Primary]
GS1	14719896530074 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233336

FDA Product Code

• PGY: Display, Diagnostic Radiology

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: 2024-11-06
• Device Publish Date: 2024-10-29

On-Brand Devices [LUMIN]

• 04719896530077: 21.3" 3MP Color LCD Medical Display
• 14719896530067: 21.3" 5MP Color LCD Medical Display