FDA UDI
In Commercial Distribution
🇺🇸 United States
Kernel
DI: 06928798600124
·
Model: KN-4003BL2S
·
Xuzhou Kernel Medical Equipment Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kernel
- Primary DI
- 06928798600124
- Version / Model
- KN-4003BL2S
- Company Name
- Xuzhou Kernel Medical Equipment Co., Ltd.
- Labeler DUNS
- 530873660
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-08
- Public Version
- 1
- Public Version Date
- 2019-03-18
- Public Version Status
- New
- Public Device Record Key
- b56754d5-58d7-4196-8ff6-0438bd5c8127
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | General, Plastic Surgery | 878.4630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34669 | Ultraviolet phototherapy unit, home-use | A mains electricity (AC-powered), portable, device that includes a lamp which emits light in the ultraviolet (UV) band intended to treat dermatological disorders (e.g., psoriasis, dermatitis) in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06928798600124 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181805 | 000 |