FDA Registration
Active
🇺🇸 United States
KCI USA, INC.
Reg #: 3005178245
·
FEI: 3005178245
·
Expires 2026
Products
3
Proprietary Names
0
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- KCI USA, INC.
- Registration Number
- 3005178245
- FEI Number
- 3005178245
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6203 FARINON DR.
- City
- SAN ANTONIO
- State
- TX
- ZIP
- 78249
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220660
Owner / Operator
- Firm Name
- Solventum US LLC
- Operator Number
- 10091183
- Address
- 12930 IH 10 West
- City
- San Antonio
- State
- TX
- Postal Code
- 78249
- Country
- US
- Correspondent
- JEFFERY J SCHORR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2022-07-06 |
| Negative Pressure Wound Therapy Device For Reduction Of Wound Complications | QFC | Class 2 | General, Plastic Surgery | No | 2022-07-06 |
| Negative Pressure Wound Therapy Non-Powered Suction Apparatus | OKO | Class 2 | General, Plastic Surgery | No | 2019-11-14 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility