FDA Registration
Active
🇺🇸 United States
OxySpur Lite Oxygen Diffusion Dressing, 2x8, Adhesive
Reg #: 3008139322
·
FEI: 3009589269
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ELECTROCHEMICAL OXYGEN CONCEPTS
- Registration Number
- 3008139322
- FEI Number
- 3009589269
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12500 Network Blvd Ste 310
- City
- San Antonio
- State
- TX
- ZIP
- 78249
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090681
Owner / Operator
- Firm Name
- Electrochemical Oxygen Concepts dba EO2 Concepts
- Operator Number
- 10030899
- Address
- 12500 Network, Suite 310
- City
- San Antonio
- State
- TX
- Postal Code
- 78249
- Country
- US
- Correspondent
- Mark Q Niederauer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chamber, Oxygen, Topical, Extremity | KPJ | Class 2 | General, Plastic Surgery | No | 2009-11-25 |
Proprietary Names
OxySpur Lite Oxygen Diffusion Dressing, 2x8, Adhesive
Extension Set, 72"
TransCu O2 Battery Charger and Cordset
OxySpur Oxygen Diffusion Dressing, 2x2, Non-Adhesive
TransCu O2 Starter Kit
OxySpur Oxygen Diffusion Dressing, 4x5, Non-Adhesive
Carrying Case
Dual Port Cannula, 36"
OxyGeni Power Pack
USB Charger
Humidicant Pack
OxySpur Oxygen Diffusion Dressing, 2x2, Adhesive
OxySpur Oxygen Diffusion Dressing, 4x5, Adhesive
OxyGeni Starter Kit
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device