FDA Registration
Active
🇺🇸 United States
Sedation Systems LLC
Reg #: 3007143859
·
FEI: 3007143859
·
Expires 2026
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- Sedation Systems LLC
- Registration Number
- 3007143859
- FEI Number
- 3007143859
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 150 Pinellas Bayway South, Suites 207, 208
- City
- Tierra Verde
- State
- FL
- ZIP
- 33715
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160950
Owner / Operator
- Firm Name
- Sedation System, LLC
- Operator Number
- 10026795
- Address
- 150 Pinellas Bayway South, Suites 207, 208
- City
- Tierra Verde
- State
- FL
- Postal Code
- 33715
- Country
- US
- Correspondent
- Ramses Nashed
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2014-03-21 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2017-05-11 |
| Apparatus, Gas-Scavenging | CBN | Class 2 | Anesthesiology | No | 2017-05-11 |
Proprietary Names
Disposable Breathing Circuit and Mask Kit
Nitroscav
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility