FDA Registration
Active
🇺🇸 United States
V8800 Critical Care Ventilator
Reg #: 3009129579
·
FEI: 3009129579
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Oricare Inc.
- Registration Number
- 3009129579
- FEI Number
- 3009129579
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1900 Am Dr
- City
- Quakertown
- State
- PA
- ZIP
- 18951
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120931
Owner / Operator
- Firm Name
- Oricare Inc.
- Operator Number
- 10036506
- Address
- 1900 AM Drive
- City
- Quakertown
- State
- PA
- Postal Code
- 18951
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2013-06-20 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2013-06-20 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2013-06-20 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2013-06-20 |
Proprietary Names
V8800 Critical Care Ventilator
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility