FDA.reportPublic FDA data

LUMIN

Primary DI
04719896530060
Brand
LUMIN
Company
ACULA TECHNOLOGY CORPORATION
Model
UMD5-21B01
Device description
"21.3"" 5MP Color LCD Medical Display"
Published
2024-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PGYDisplay, Diagnostic Radiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGYDisplay, Diagnostic RadiologyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K24149900021.3” 5MP Color LCD Display UMD5-21B01Acula Technology Corp.2024-06-13PGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719896530067PackageGS11In Commercial Distribution
04719896530060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471989653006714719896530067
04719896530060047198965300604719896530060

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn 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.

Regulatory Flags#

DUNS number
656742004
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14719896530067LUMINUMD5-21B012024-10-29
04719896530077LUMINUMD3-21B012024-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04995047069300RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047069362RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072676RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072683RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072843RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072904RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072935RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072973RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073055RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073185RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073208RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073277RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073338RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073376RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073444RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073468RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073475RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073611RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073673RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073703RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073819RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073871RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073895RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074311RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074373RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074441RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074588RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074601RadiForce®EIZO CORPORATIONPGY2026-07-22
08809241513148CW60NWIDE corporationPGY2026-07-16
08809241513155CL24NWIDE corporationPGY2026-07-16