FDA.reportPublic FDA data

neoBLUE Radiometer

Primary DI
07640158712146
Brand
neoBLUE Radiometer
Company
Derungs Licht AG
Model
D16236000
Catalog number
D16236000
Device description
Blue light radiometer: An instrument designed to measure the radiant flux (radiant power) in the spectral range of 400 to 500 nm(i.e., blue) during bilirubinemia treatment for newborns and infants
Published
2023-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640158712146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640158712146076401587121467640158712146

GMDN Terms#

Term, Definition table
TermDefinition
Blue light radiometerAn instrument designed to measure the radiant flux (radiant power) in the spectral range of 400 to 500 nm (i.e., blue) during bilirubinemia treatment for newborns and infants. It typically includes a pre-filter intended to remove wavelengths of light not in the 400-500 nm range (e.g., infrared light); a primary detector consisting of a temperature-stabilized, solid-state [e.g., selenium (Se) or indium-gallium-arsenide] device used to detect radiation; electronic circuits including an amplifier and a electric meter; a power source (e.g., a battery); and a display showing the results either in analogue or digital format.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481027886
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640158711514Giraffe PT Light MeterD1610300056974492021-06-22
07640158710241VISIANO 10-1P S10D157800002019-02-07
07640158710258VISIANO 10-1P S10D157810002019-02-07
07640158710265VISIANO 10-1P S10D157820002019-02-07
07640158710272VISIANO 10-1P S10D157830002019-02-07
07640158710289VISIANO 10-1P S10D157840002019-02-07
07640158710296VISIANO 10-1P S10D159370002019-02-07
07640158710302VISIANO 10-1P S10D159380002019-02-07
07640158710319VISIANO 10-1P S10D159590002019-02-07
07640158710326VISIANO 10-1P S10D159600002019-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00816870020068PrisMatic ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
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07290016923391BreathID Hp Lab Device (WIN)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
00860011967743ZELLECHEM-PROSTERILE SAFEQUIP & CHEMICALS LLPJJQ2024-07-09
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungJJQ2023-09-02
00840239052520DRG:HYBRiD.XL®DRG International IncJJQ2023-08-26
10810138822705EndocatorEndo Direct LLCJJQ2023-07-16
09120052071184SUNRISETecan Austria GmbHJJQ2023-07-06
09120052071191SUNRISE-RC/ST EVOLYZERTecan Austria GmbHJJQ2023-07-06
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09120052071214SUNRISE-RC/6F EVOLYZERTecan Austria GmbHJJQ2023-07-06
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06936895300212BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
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00850229007010StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05