FDA Registration
Active
🇺🇸 United States
ULTI MED, INC.
Reg #: 2183771
·
FEI: 2183771
·
Expires 2026
Products
4
Proprietary Names
23
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- ULTI MED, INC.
- Registration Number
- 2183771
- FEI Number
- 2183771
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 710 Fourth Street
- City
- De Smet
- State
- SD
- ZIP
- 57231
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213407
Owner / Operator
- Firm Name
- ULTI MED, INC.
- Operator Number
- 2183771
- Address
- 350 Highway 7, --
- City
- Excelsior
- State
- MN
- Postal Code
- 55331
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-12-20 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2008-01-21 |
| Container, Sharps | MMK | Class 2 | General Hospital | No | 2008-07-15 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2015-07-02 |
Proprietary Names
UltiCare Disposable Pen Needles
Simpli
Health Mart. PHARMACY
Sunmark
GOOD NEIGHBOR PHARMACY
Life Brand
UltiCare
Others
UltiCare syringes
UltiGuard Home Insulin Pen Needle
AND OTHERS
ULTICARE DISPOSABLE NEEDLES
SHINA
Ulti Guard
UltiCare 3 mL Luer Lock Safety Syringes with Needles
UltiCare Disposable Pen Needles
Health Mart PHARMACY
Publix
UltiCare disposable pen needles
Procure
UltiCare Safety Insulin Syringe
Assure ID Insulin Safety Syringes
One-Care
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility