FDA Registration
Active
🇺🇸 United States
Solventum US LLC
Reg #: 3031757047
·
FEI: 3031757047
·
Expires 2026
Products
24
Proprietary Names
6
Establishment Types
3
Classifications
24
Registration Details
- Registration Name
- Solventum US LLC
- Registration Number
- 3031757047
- FEI Number
- 3031757047
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 601 22nd Ave S
- City
- Brookings
- State
- SD
- ZIP
- 57006
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121171
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 |
|---|---|---|---|---|---|
| Cap, Device Disinfectant | QBP | Class 2 | General Hospital | No | 2019-04-01 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2025-07-15 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2007-12-06 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Drape, Urological, Disposable | EYY | Class 2 | General, Plastic Surgery | No | 2020-07-07 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-07-10 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2025-12-18 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-10-29 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2017-12-13 |
| Ring (Wound Protector), Drape Retention, Internal | KGW | Class 2 | General, Plastic Surgery | No | 2020-07-07 |
| Central Venous Catheter Dressing Change Kit | PEZ | Class 2 | General Hospital | No | 2014-12-12 |
| Antimicrobial Drapes | PLY | Class 2 | General, Plastic Surgery | No | 2024-07-10 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2024-07-10 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2004-01-28 |
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | Class 2 | General Hospital | No | 2022-09-06 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2007-12-06 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 1995-03-03 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2024-11-19 |
| Securement Wound Dressing For Reduction Of Infection | SEL | Class U | Unknown | No | 2019-11-21 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2004-01-28 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2024-07-18 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-07 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2025-02-21 |
Proprietary Names
3M¿ Attest¿ Auto-Reader
Defib Pads
3M
Attest Rapid Readout 1291
3M¿ Ioban¿ 2
3M¿ Steri-Drape¿ Ioban¿ 2
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)