Identity
- Trade Name
- BiliTouchTM FDA UDI
- Generic Name
- Overhead infant phototherapy unit FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Motif Phototherapy Blanket FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800012345012 FDA UDI
- 510(k) Number
- K210289 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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Overhead infant phototherapy unit
BiliTouchTM by Bistos Co., Ltd. — 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
- bili-hut™ — Little Sparrows Technologies, Inc. · Class II
- bili-hut™ — Little Sparrows Technologies, Inc. · Class II
- bili-hut™ — Little Sparrows Technologies, Inc. · Class II
- bili-hut™ — Little Sparrows Technologies, Inc. · Class II
- bili-hut™ — Little Sparrows Technologies, Inc. · Class II
- bili-hut™ — Little Sparrows Technologies, Inc. · Class II
- bili-hut™ — Little Sparrows Technologies, Inc. · Class II
Cleared under the same submission
K210289 also covers:
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 |
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Manufacturer
- Manufacturer
- Bistos Co., Ltd.
Sources (1)
- FDA UDI e91f1507-7b0f-43b3-b13b-60250257ed70 35 fields · synced May 30, 2026