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Sign in to claim this brandULTI MED, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 710 Fourth Street, De Smet, SD, 57231
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2183771
- DUNS Number
- —
Catalogue (116)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Simpli | 74552 | FDA UDI | Class II | Active |
| UltiCare | 71012 | FDA UDI | Class II | Active |
| UltiCare | 71007 | FDA UDI | Class II | Active |
| UltiCare | 0319PL | FDA UDI | Class II | Active |
| Coborns/UltiGuard | 09543CB | FDA UDI | Class II | Active |
| Simpli | 74582 | FDA UDI | Class II | Active |
| Simpli | 74501 | FDA UDI | Class II | Active |
| Benzer/UltiGuard | 09553BZ | FDA UDI | Class II | Active |
| Ulticare Disposable Syringes And Needles | K062702 | FDA 510(k) | Class II | Active |
| Ultimed Ulticare Safety Syringe | K080600 | FDA 510(k) | Class II | Active |
| Ultiguard Home Insulin Pen Needle Dispenser And Sharps Container | K081449 | FDA 510(k) | Class II | Active |
| Ulticare Disposable Pen Needles | K100812 | FDA 510(k) | Class II | Active |
| Ulticare Disposable Syringe | K994230 | FDA 510(k) | Class II | Active |
| Ulticare Disposable Syringe 3 Ml/Cc | K033794 | FDA 510(k) | Class II | Active |
| Ulti Guard Home Insulin Syringe Container | K021983 | FDA 510(k) | Class II | Active |
| Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2 | K050464 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 5, 2010 | Z-1217-2010 | — | terminated | UltiMed, Inc. is recalling one lot of 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe Live Better because it is mislabeled and actually contains 1/2 cc, 30 gauge x 1/2 inch U-100 insulin Syringe. |