FDA.reportPublic FDA data

KENEX

Primary DI
05055449410397
Brand
KENEX
Company
KENEX (ELECTRO-MEDICAL) LIMITED
Model
300/L-LED150FP
Catalog number
300/L-LED150FP
Device description
LED 150FP Lamp and suspension arm only (for use with a Kenex celling radiation shield) inclu PSU
Published
2023-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KZFDevice, Medical Examination, Ac Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZFDevice, Medical Examination, Ac PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055449410397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055449410397050554494103975055449410397

GMDN Terms#

Term, Definition table
TermDefinition
Fixed examination/treatment room lightA fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
217421064
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055449412490Kenex312/E-040/P312/E-040/P2026-04-27
05055449412445Kenex312/E-040312/E-0402026-04-24
05055449412438Kenex351/68/LED130F-0031351/68/LED130F-00312026-02-09
05055449412414Kenex312/E-020/3/P312/E-020/3/P2026-01-20
05055449412407Kenex313/A2-025313/A2-0252026-01-07
05055449412353Kenex312/DS-070312/DS-0702025-10-24
05055449412360Kenex312/DS-071312/DS-0712025-10-24
05055449412179Kenex313/A2-024313/A2-0242025-10-07
05055449412285Kenex354/P/88-207/LR354/P/88-207/LR2025-09-10
05055449409933Kenex354/P/76-107354/P/76-1072025-06-09
05055449412223Kenex354/P/76-207354/P/76-2072025-06-06
05055449405522KENEX312/E-023/P312/E-023/P2025-02-24
05055449412087KENEX313/A2-023313/A2-0232025-02-24
05055449412056KENEX313/A2/3.34313/A2/3.342025-01-16
05055449412070KENEX312/DS-0412/4312/DS-0412/42025-01-13
05055449412063KENEX313/A2-022313/A2-0222025-01-06
05055449411950KENEX312/E-017312/E-0172024-12-09
05055449411967KENEX312/E-017/8312/E-017/82024-12-09
05055449411974KENEX312/E-017/P312/E-017/P2024-12-09
05055449411981KENEX312/E-017/8P312/E-017/8P2024-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095543954zumaxZumax Medical Co., LTDKZF2026-05-21
00858480006339NOVABurton Medical, LLCKZF2026-04-02
00858480006346 NOVABurton Medical, LLCKZF2026-04-02
00858480006827 OPLEDBurton Medical, LLCKZF2026-04-02
00858480006834 AIM HIBurton Medical, LLCKZF2026-04-02
00858480006841 AIM HIBurton Medical, LLCKZF2026-04-02
00858480006858 AIM LEDBurton Medical, LLCKZF2026-04-02
00724995244286HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244309HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244330HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244347HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244378HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244293HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244354HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244361HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244385HexaLuxSTERIS CORPORATIONKZF2025-05-05
04250365155471ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155488ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155495ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155839ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155860ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365174434ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365174441ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365175530ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365189797ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
00724995225070NASTERIS CORPORATIONKZF2024-11-25
00724995225179NASTERIS CORPORATIONKZF2024-11-25
00724995225186NASTERIS CORPORATIONKZF2024-11-25
00724995225667NASTERIS CORPORATIONKZF2024-11-25
00724995225674NASTERIS CORPORATIONKZF2024-11-25