FDA UDI
In Commercial Distribution
🇺🇸 United States
CLEO HPA
DI: G6199131371410
·
Model: 400 /30 SD L
·
JW NORTH AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CLEO HPA
- Primary DI
- G6199131371410
- Version / Model
- 400 /30 SD L
- Catalog Number
- 913137141
- Company Name
- JW NORTH AMERICA, INC.
- Labeler DUNS
- 039280558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-01
- Public Version
- 1
- Public Version Date
- 2024-08-09
- Public Version Status
- New
- Public Device Record Key
- cc2183cd-86af-4fab-bf55-1f8d1329ce1b
Device Description
Ultraviolet tanning device
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LEJ | Booth, Sun Tan | General, Plastic Surgery | 878.4635 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46387 | Ultraviolet tanning device | A mains electricity (AC-powered) lamp or bed/booth with lamps designed to provide radiation in the ultraviolet spectrum for tanning the skin. This device is used for cosmetic purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | G6199131371411 | HIBCC | carton box | 25 | In Commercial Distribution | |
| Primary | G6199131371410 | HIBCC | ||||
| Previous | B5331180560 | HIBCC |