FDA Registration
Active
🇺🇸 United States
SMD MANUFACTURING LLC
Reg #: 3013075752
·
FEI: 3013075752
·
Expires 2026
Products
8
Proprietary Names
3
Establishment Types
4
Classifications
8
Registration Details
- Registration Name
- SMD MANUFACTURING LLC
- Registration Number
- 3013075752
- FEI Number
- 3013075752
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 918 S 500 W STE A
- City
- Salt Lake City
- State
- UT
- ZIP
- 84101
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231064
Owner / Operator
- Firm Name
- SMD Manufacturing LLC
- Operator Number
- 10052202
- Address
- 918 S 500 W STE A
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84101
- Country
- US
- Correspondent
- Stephanie Hess
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2019-03-06 |
| Airway Suction Kit | OFO | Class 1 | Anesthesiology | No | 2024-05-08 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2016-11-29 |
| Dental Hygiene Kit | NXZ | Class 1 | Dental | No | 2024-05-08 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2018-03-29 |
| Ventilator, Continuous, Non-Life-Supporting | MNS | Class 2 | Anesthesiology | No | 2024-01-03 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2021-08-31 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2016-08-29 |
Proprietary Names
U-Tube
SMD
ReddyPort NIV Access Elbow
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility