FDA UDI
In Commercial Distribution
🇺🇸 United States
bili-hut™ fully disposable nest & mattress (5-Pack)
DI: 00810101280504
·
Model: 0133AFD5
·
LITTLE SPARROWS TECHNOLOGIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- bili-hut™ fully disposable nest & mattress (5-Pack)
- Primary DI
- 00810101280504
- Version / Model
- 0133AFD5
- Company Name
- LITTLE SPARROWS TECHNOLOGIES LLC
- Labeler DUNS
- 078764736
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-26
- Public Version
- 2
- Public Version Date
- 2024-04-22
- Public Version Status
- Update
- Public Device Record Key
- 5a6ada0c-efc2-468c-9b2b-316a19e503d8
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 | 00810101280504 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190899 | 000 |