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
| Company | Devices | Share |
|---|---|---|
| Little Sparrows Technologies Llc | 40 | 65% |
| Datex-Ohmeda, Inc. | 6 | 10% |
| Bistos Co., Ltd. | 4 | 6% |
| Atom Medical Corporation | 3 | 5% |
| Advanced Instrumentations, Inc. | 3 | 5% |
| Natus Medical Denmark Aps | 2 | 3% |
| Draeger Medical Systems, Inc. | 1 | 2% |
| International Biomedical, Ltd. | 1 | 2% |
| Physician Engineered Products Inc | 1 | 2% |
| Medela Ag | 1 | 2% |
Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| LBI | Unit, Neonatal Phototherapy | 59 |
| LBI | UNIT, NEONATAL PHOTOTHERAPY | 6 |
| FMZ | INCUBATOR, NEONATAL | 2 |
| PDH | Blanket, Neonatal Phototherapy | 1 |
Use these as the dimensions to specify in a tender line.
62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Overhead infant phototherapy unit", from 10 companies. The largest labeler is Little Sparrows Technologies Llc with 65% of records.
LBI (Unit, Neonatal Phototherapy), LBI (UNIT, NEONATAL PHOTOTHERAPY), FMZ (INCUBATOR, NEONATAL), PDH (Blanket, Neonatal Phototherapy)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.