FDA.reportPublic FDA data

JVC

Primary DI
00046838076572
Brand
JVC
Company
JVC KENWOOD CORPORATION
Model
CCL258i2/N
Device description
2MP Color LCD Monitor CL21258-J00U
Published
2017-05-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K13318100021.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)Jvckenwood Corporation2013-12-03LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00046838076572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00046838076572000468380765720468380765720046838076572

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This group of devices is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
713321040
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00046838501111JVCCL-S3012024-08-19
00046838002687JVCCL-R8132023-01-05
00046838076350JVCCCL358i2/N2017-04-01
00046838076367JVCCCL358i2/F2017-04-01
00046838076374JVCCCL550i2/N2017-04-01
00046838076381JVCCCL550i2/F2017-04-01
00046838076411JVCMS55i2 plus2017-09-01
00046838076435JVCMS55i2 plus2017-09-01
00046838076510JVCMS35i2/F2017-05-01
00046838076527JVCMS35i2/N2017-05-01
00046838076534JVCMS35i2/AR2017-05-01
00046838076541JVCMS25i2/F2017-05-01
00046838076558JVCMS25i2/N2017-05-01
00046838076565JVCMS25i2/AR2017-05-01
00046838076589JVCCCL258i2/AR2017-05-01
00046838076596JVCCCL258i2/F2017-05-01
00046838076602JVCCCL650i2/N2017-05-01
00046838076619JVCCCL650i2/AR2017-05-01
00046838076626JVCCCL2142017-05-01
00046838077524JVCCL-S3002018-01-01

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Primary DI, Brand, Company table
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