Bili-Hut™
bili-hut is a portable blue-LED phototherapy device for neonatal jaundice in clinical or home settings. Its light array is built into a shell positioned over the infant's treatment nest.…
bili-hut is a portable blue-LED phototherapy device for neonatal jaundice in clinical or home settings. Its light array is built into a shell positioned over the infant’s treatment nest.
Blue light converts bilirubin into forms that can pass out of the infant’s body. The device has one operating mode, controlled by an on/off switch; light intensity and wavelength are fixed rather than user-adjustable.
Listed Item
Neonatal Jaundice Phototherapy Device
Treatment Components
The assembly includes the shell, base, mattresses, nest and liners, with a medical-grade power supply. A timer records total LED operating hours rather than an individual infant’s treatment time. An optional perch supports use with a hospital bassinet stand.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Little Sparrows Technologies Inc, United States |
|---|---|
| FDA product code | LBI |
| Device type | Unit, Neonatal Phototherapy |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5700 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K190899 |
| Record published | 2022-03-10 |
| Record revised | 2024-04-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution | |
| 0130A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 10 |
| neoBLUE | Natus Medical Incorporated | 9 |
| Bilisoft 2.0 | Lumitex, Inc. | 4 |
| BiliSoft Phototherapy System | Datex-Ohmeda, Inc. | 3 |
| Lamp | RPI | 3 |
| Giraffe Blue Spot PT Lite | Datex-Ohmeda, Inc. | 2 |
| BiliCocoon™ Nest System | Neomedlight | 2 |
| BiliCocoon™ Bag System | Neomedlight | 2 |
| BiliCocoon™ Nest Disposable | Neomedlight | 2 |
| Unit, Neonatal Phototherapy | Bistos Co., Ltd. | 2 |
| BiliCocoon™ Bag Pad | Neomedlight | 2 |
| NeoBLUE Nova | Natus Medical Denmark ApS | 2 |
Showing 12 of 61. All products under Unit, Neonatal Phototherapy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190899 | 2019-09-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.