FDA UDI
In Commercial Distribution
🇺🇸 United States
BiliSoft Phototherapy System
DI: 00840682116565
·
Model: BI1
·
DATEX-OHMEDA INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BiliSoft Phototherapy System
- Primary DI
- 00840682116565
- Version / Model
- BI1
- Company Name
- DATEX-OHMEDA INC
- Labeler DUNS
- 131483356
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-24
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b65c742e-d768-4f79-aaae-49223d885775
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LBI | UNIT, NEONATAL PHOTOTHERAPY | General Hospital | 880.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35239 | Overhead infant phototherapy unit | A mains electricity (AC-powered) device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (hyperbilirubinemia). It consists of an overhead lamp consisting of several, daylight, cool white, blue, or special blue fluorescent light tubes and a Plexiglas shield placed between the phototherapy lights and the newborn to filter out ultraviolet (UV) radiation. Exposure to this device will alter the bilirubin through photo-oxidation, and configurational and structural isomerization, allowing the body to dispose of it naturally. It will typically have a built-in timer, but some may have a separate timer unit connected. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840682116565 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053568 | 000 |