FDA Registration
Active
🇺🇸 United States
TXP-2D Transport Ventilator
Reg #: 1625392
·
FEI: 1000058335
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INTERNATIONAL BIOMEDICAL, LTD.
- Registration Number
- 1625392
- FEI Number
- 1000058335
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8206 Cross Park Dr
- City
- AUSTIN
- State
- TX
- ZIP
- 78754
- Country
- US
Regulatory Submissions
- 510(k) Number
- K905234
Owner / Operator
- Firm Name
- INTERNATIONAL BIOMEDICAL, LTD.
- Operator Number
- 1629497
- Address
- 8206 CROSS PARK DR., P.O. BOX 143449
- City
- Austin
- State
- TX
- Postal Code
- 78754
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2025-03-31 |
Proprietary Names
TXP-2D Transport Ventilator
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device