FDA Registration
Active
🇺🇸 United States
SpectraShield
Reg #: 3037969189
·
FEI: 3037969189
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NEXERA MEDICAL LLC
- Registration Number
- 3037969189
- FEI Number
- 3037969189
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9429 Harding Avenue # 293
- City
- Surfside
- State
- FL
- ZIP
- 33154
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120244
Owner / Operator
- Firm Name
- Nexera Medical LLC
- Operator Number
- 10093260
- Address
- 9429 Harding Avenue # 293
- City
- Surfside
- State
- FL
- Postal Code
- 33154
- Country
- US
- Correspondent
- Akhil Agrawal
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| N95 Respirator With Antimicrobial/Antiviral Agent | ONT | Class 2 | General, Plastic Surgery | No | 2025-04-21 |
Proprietary Names
SpectraShield
N95 respirator with antimicrobial/antiviral agent
Establishment Types
Manufacture Medical Device