Identity
- Trade Name
- Kernel FDA UDI
- Generic Name
- Ultraviolet phototherapy unit, home-use FDA UDI
- Model / Reference
- KN-4003B3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06928798600384 FDA UDI
- 510(k) Number
- K242977 FDA UDI
- FDA Product Code
- FTC FDA UDI
- GMDN Term
- Ultraviolet phototherapy unit, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4630 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
No
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
Category: Ultraviolet phototherapy unit, home-use
Kernel by Xuzhou Kernel Medical Equipment Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultraviolet phototherapy unit, home-use.
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Cleared under the same submission
K242977 also covers:
- Kernel — Xuzhou Kernel Medical Equipment Co., Ltd.
- Kernel — Xuzhou Kernel Medical Equipment Co., Ltd.
- Kernel — Xuzhou Kernel Medical Equipment Co., Ltd.
- Kernel — Xuzhou Kernel Medical Equipment Co., Ltd.
- Kernel — Xuzhou Kernel Medical Equipment Co., Ltd.
- Kernel — Xuzhou Kernel Medical Equipment Co., Ltd.
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
- Xuzhou Kernel Medical Equipment Co., Ltd.
Sources (1)
- FDA UDI 99bee6a3-6d66-4fcb-8806-35cab8715878 33 fields · synced Jun 8, 2026