Infant Phototherapy Equipment
The BT-450 Infant Phototherapy Equipment treats neonatal unconjugated hyperbilirubinaemia using blue light. It is intended for infants up to three months old weighing less than 10 kg, with…
The BT-450 Infant Phototherapy Equipment treats neonatal unconjugated hyperbilirubinaemia using blue light. It is intended for infants up to three months old weighing less than 10 kg, with treatment in a hospital or at home.
Blue LEDs in a pad provide light from underneath the infant. The portable system includes a control box, disposable pad cover, rechargeable battery and AC/DC power supply, with two selectable light-intensity levels.
Listed Item
This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home. The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
Treatment Light
The LEDs deliver light within the stated 400 to 550 nm band. The pad and control system provide phototherapy while bilirubin response determines the course of treatment.
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 | Bistos Co., Ltd., South Korea |
|---|---|
| FDA product code | LBI |
| Device type | Unit, Neonatal Phototherapy |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5700 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K210289 |
| Record published | 2021-06-08 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Carton box of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BT-450 | 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™ Bag System | Neomedlight | 2 |
| BiliCocoon™ Nest Disposable | Neomedlight | 2 |
| Unit, Neonatal Phototherapy | Bistos Co., Ltd. | 2 |
| BiliCocoon™ Bag Pad | Neomedlight | 2 |
Showing 12 of 61. All products under Unit, Neonatal Phototherapy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210289 | 2021-05-28 |
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.