FDA Registration
Active
🇺🇸 United States
QiVi Male External Urine Management Device
Reg #: 3013524793
·
FEI: 3013524793
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- CM Technologies, Inc.
- Registration Number
- 3013524793
- FEI Number
- 3013524793
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1321 Valwood Parkway, Suite 530
- City
- Carrollton
- State
- TX
- ZIP
- 75006
- Country
- US
Owner / Operator
- Firm Name
- CM Technologies, Inc.
- Operator Number
- 10049590
- Address
- 1321 Valwood Parkway,, Suite 530,
- City
- Carrollton
- State
- TX
- Postal Code
- 75006
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | Class 1 | Gastroenterology, Urology | No | 2020-05-04 |
Proprietary Names
QiVi Male External Urine Management Device
QiVi Female External Urine Management Device
QiVi Automated Urine Management Device
AUM Drainage Tubing
AUM Canister
QiVi Acute Male External Urine Management Device
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198