Identity
- Trade Name
- bili-hut™ FDA UDI
- Generic Name
- Overhead infant phototherapy unit FDA UDI
- Model / Reference
- 0130A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850019925722 FDA UDI00810101280047 FDA UDI00850019925876 FDA UDI00850019925494 FDA UDI
- 510(k) Number
- K190899 FDA UDI
- FDA Product Code
- LBI FDA UDI
- GMDN Term
- Overhead infant phototherapy unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Overhead infant phototherapy unit
bili-hut™ by Little Sparrows Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Overhead infant phototherapy unit.
- Lullaby — Datex-Ohmeda Inc. · Class II
- Giraffe Blue Spot PT Lite — Datex-Ohmeda Inc. · Class II
- Airborne Phototherapy Light — INTERNATIONAL BIOMEDICAL, LTD. · Class II
- BiliLux Phototherapy Light — Draeger Medical Systems, Inc. · Class II
- neoBLUE Compact LED Phototherapy System — Natus Medical Incorporated · Class II
- ADVANCED LED PHOTOTHERAPY LAMP — ADVANCED INSTRUMENTATIONS, INC. · Class II
- ADVANCED LED PHOTOTHERAPY LAMP — ADVANCED INSTRUMENTATIONS, INC. · Class II
- BiliSoft Phototherapy System — Datex-Ohmeda Inc. · Class II
Cleared under the same submission
K190899 also covers:
- bili-hut™ — Little Sparrows Technologies, Inc.
- bili-hut™ — Little Sparrows Technologies, Inc.
- bili-hut™ — Little Sparrows Technologies, Inc.
- bili-hut™ — Little Sparrows Technologies, Inc.
- bili-hut™ — Little Sparrows Technologies, Inc.
- bili-hut™ — Little Sparrows Technologies, Inc.
- bili-hut™ — Little Sparrows Technologies, Inc.
- bili-hut™ — Little Sparrows Technologies, Inc.
- bili-hut™ — Little Sparrows Technologies, Inc.
- bili-hut™ — Little Sparrows Technologies, Inc.
- bili-hut™ — Little Sparrows Technologies, Inc.
- bili-hut™ — Little Sparrows Technologies, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Little Sparrows Technologies, Inc.
Sources (4)
- FDA UDI 10e99f72-f7e2-45bd-8e8d-8d4942173931 33 fields · synced Jun 7, 2026
- FDA UDI eb16ac07-a8e4-490e-bfec-8d62f32cbe0c 33 fields · synced May 25, 2026
- FDA UDI 0c2ad0e3-7a66-4854-b59d-5d1b351d547f 33 fields · synced May 25, 2026
- FDA UDI 4438a420-eb28-47dd-b36b-680fce9dced2 33 fields · synced May 26, 2026