FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CLEO SWIFT / 80W
DI: 04014501003381
·
Model: FR59 T12 80W PH / BiPin
·
NARVA Lichtquellen GmbH + Co KG.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CLEO SWIFT / 80W
- Primary DI
- 04014501003381
- Version / Model
- FR59 T12 80W PH / BiPin
- Catalog Number
- 9865 7174 0
- Company Name
- NARVA Lichtquellen GmbH + Co KG.
- Labeler DUNS
- 330119702
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- ae18851a-7f09-4a03-99fa-4b063fb8fe18
- Distribution End Date
- 2017-12-08
Device Description
UV - Tanning lamp, Accession # 102 0131-000 <CR> Exclusive distributor for USA: JW North America, Inc., 233 Libbey Industrial Pkwy, Unit 2, Weymouth, MA 02189, Phone: +1 781 331 0949, Email: [email protected] <CR> Manufacturer: NARVA Lichtquellen GmbH + Co. KG, Industriegebiet Nord, Erzstrasse 22, 09618 Brand-Erbisdorf, Germany, Phone: +49 37322 17 200, Email: [email protected], http://www.narva-bel.de
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
- Yes
- Has Expiration Date
- Yes
- 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 | 84014501003387 | GS1 | Pallet | 20 | Not in Commercial Distribution | 2017-12-08 |
| Package | 54014501503381 | GS1 | Tertiary Packaging | 25 | Not in Commercial Distribution | 2017-12-08 |
| Primary | 04014501003381 | GS1 |
Customer Contacts
- Phone
- +1 781 331 0949
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Attention: Fragile.