FDA UDI
In Commercial Distribution
🇺🇸 United States
neoBLUE Radiometer
DI: 07640158712146
·
Model: D16236000
·
Derungs Licht AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- neoBLUE Radiometer
- Primary DI
- 07640158712146
- Version / Model
- D16236000
- Catalog Number
- D16236000
- Company Name
- Derungs Licht AG
- Labeler DUNS
- 481027886
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-30
- Public Version
- 1
- Public Version Date
- 2023-06-07
- Public Version Status
- New
- Public Device Record Key
- d60bde20-d7a2-4010-9e04-d02e3c21b862
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
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
- Yes
- 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 |
|---|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | Clinical Chemistry | 862.2300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47701 | 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. 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640158712146 | GS1 |