FDA Registration
Active
🇺🇸 United States
XENA COOL LLC
Reg #: 3016555200
·
FEI: 3016555200
·
Expires 2026
Products
1
Proprietary Names
27
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- XENA COOL LLC
- Registration Number
- 3016555200
- FEI Number
- 3016555200
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 957 Tile Drive
- City
- Red Wing
- State
- MN
- ZIP
- 55066
- Country
- US
Owner / Operator
- Firm Name
- XENA VENTURES LLC
- Operator Number
- 10062560
- Address
- 145 Maple Hill Rd
- City
- Hopkins
- State
- MN
- Postal Code
- 55343
- Country
- US
- Correspondent
- Tammy Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2020-02-13 |
Proprietary Names
ONYX COOL Knee - SkinSafe 58
Opal Cool Crown - SkinSafe 58
Opal Cool Shoulder/Foot+ - Skin Safe 58
Opal Cool Eye Need to Chill - SkinSafe 58
ONYX COOL VEST - CoolNow 80
Opal Cool Gal Pals Chill - SkinSafe 58
Opal Cool Pad - CoolNow 80
ONYX COOL Shoulder/Foot+ - SkinSafe 58
Opal Cool Hot Flash Cape - SkinSafe 58
ONYX COOL Chill Minis - SkinSafe 58
Opal Cool Wrap - CoolNow 80
Opal Cool Eye Mask - SkinSafe 58
ONYX COOL PAD - CoolNow 80
ONYX COOL VEST - SkinSafe 58
Opal Cool Wrap - SkinSafe 58
Opal Cool Breast Friends - SkinSafe 58
Opal Cool Got You Covered - SkinSafe 58
Opal Cool Gal Pals Go - CoolNow 80
ONYX COOL Back/Hip - SkinSafe 58
ONYX COOL Go Minis - CoolNow 80
Opal Cool Cap - SkinSafe58
ONYX COOL CAP - SkinSafe 58
Opal Cool Breast Friends - CoolNow 80
ONYX COOL Back/Hip - Cool Now 80
ONYX COOL CAP - CoolNow 80
Opal Cool One - SkinSafe58
Opal Cool Dreams - CoolNow 80
Establishment Types
Manufacture Medical Device