LUMIN

Basic Information

• Brand Name: LUMIN
• Primary DI: 04719896530060
• Version / Model: UMD5-21B01
• Company Name: ACULA TECHNOLOGY CORPORATION
• Labeler DUNS: 656742004
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-29
• Public Version: 1
• Public Version Date: 2024-11-06
• Public Version Status: New
• Public Device Record Key: 933bc680-7ca5-4ffa-8d19-a2ad3d72796c

Device Description

21.3" 5MP Color LCD Medical Display

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PGY	Display, Diagnostic Radiology	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36612	Image display unit, colour	An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14719896530067	GS1		1	In Commercial Distribution
Primary	04719896530060	GS1

Premarket Submissions

Submission Number	Supplement Number
K241499	000