BiliCocoon™ Bag System
The BiliCocoon Bag System is a prescription phototherapy device for unconjugated hyperbilirubinemia in newborns and infants younger than three months who weigh less than 10 kg. It can be…
The BiliCocoon Bag System is a prescription phototherapy device for unconjugated hyperbilirubinemia in newborns and infants younger than three months who weigh less than 10 kg. It can be used in clinical settings or at home.
The light box directs blue LED light through optical fibers into a fabric pad. The Bag Pad illuminates the baby from above and below, using light between 430 and 490 nm. The user can set the treatment session time, while irradiance and wavelength remain fixed.
Contact Cover
A fitted disposable nonwoven cover forms the interface between the pad and the infant. It is the only part that contacts the infant’s skin. The Bag Pad provides a 1200-square-centimeter treatment area, and the light box displays operating errors.
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 | Neomedlight, France |
|---|---|
| FDA product code | LBI |
| Device type | Unit, Neonatal Phototherapy |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5700 |
| Establishment | Manufacturer |
| 510(k) | K163526 |
| Record published | 2017-11-03 |
| Record revised | 2024-02-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Keep dry; Handling environment humidity 15 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 50.4 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BCC201 | In distribution | |
| BCC201 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| bili-hut™ | Little Sparrows Technologies Inc | 33 |
| 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™ 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 |
|---|---|
| K163526 | 2017-10-06 |
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.