FDA Registration
Active
🇺🇸 United States
Carecube Negative Pressure Isolation Chamber
Reg #: 3023194188
·
FEI: 3023194188
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TPI Custom Solutions
- Registration Number
- 3023194188
- FEI Number
- 3023194188
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 13828 Lincoln St. NE
- City
- Ham Lake
- State
- MN
- ZIP
- 55304
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231256
Owner / Operator
- Firm Name
- TPI Custom Solutions
- Operator Number
- 10085509
- Address
- 13828 Lincoln St. NE
- City
- Ham Lake
- State
- MN
- Postal Code
- 55304
- Country
- US
- Correspondent
- Joe Kahl
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chamber, Patient Isolation | LGM | Class 2 | General Hospital | No | 2025-05-16 |
Proprietary Names
Carecube Negative Pressure Isolation Chamber
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)