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Sign in to claim this brandDIASOL INC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 310 S 43RD AVE, Phoenix, AZ, 85009
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3007137482
- DUNS Number
- —
Catalogue (172)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Diasol | 80225-10200 | FDA UDI | Class II | Active |
| Diasol | 80220-10200 | FDA UDI | Class II | Active |
| CitriSol | CS100325-10100 | FDA UDI | Class II | Active |
| Diasol | 80230-10200 | FDA UDI | Class II | Active |
| Diasol | 80125-10200 | FDA UDI | Class II | Active |
| Diasol | 80110-10200 | FDA UDI | Class II | Active |
| Diasol | BP8000X10T | FDA UDI | Class II | Active |
| Diasol | 80025-10200 | FDA UDI | Class II | Active |
| Diasol | 100200-75200 | FDA UDI | Class II | Active |
| Diasol | 100120-75100 | FDA UDI | Class II | Active |
| Diasol | 100430-75100 | FDA UDI | Class II | Active |
| Diasol | 100000-75200 | FDA UDI | Class II | Active |
| Shelly Protected Av Fistula Needle | K993187 | FDA 510(k) | Class II | Active |
| Dryasol Acid Concentrate Mix | K993212 | FDA 510(k) | Class II | Active |
| Citrisol Acid Concentrate | K130511 | FDA 510(k) | Class II | Active |
| Shelly Protected Av Fistula Needle | K992653 | FDA 510(k) | Class II | Active |
| Diasol-Additives | K020231 | FDA 510(k) | Class II | Active |
| Safesting And Safesting Hub | K011003 | FDA 510(k) | Class II | Active |
| Diasol-Bicarb | K020230 | FDA 510(k) | Class II | Active |
| Daisy Protected Scalp Vein Set | K992999 | FDA 510(k) | Class II | Active |
| Fistulok Fistula Needle Protection | K010958 | FDA 510(k) | Class II | Active |
| Needlelok Hypodermic Needle Protection | K011004 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (8)
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 |
|---|---|---|---|---|
| Nov 5, 2025 | Z-0987-2026 | — | open, classified | Safety and efficacy of dialysis acid concentrate cannot be assured |
| Nov 5, 2025 | Z-0991-2026 | — | open, classified | Safety and efficacy of dialysis acid concentrate cannot be assured |
| Nov 5, 2025 | Z-0989-2026 | — | open, classified | Safety and efficacy of dialysis acid concentrate cannot be assured |
| Nov 5, 2025 | Z-0988-2026 | — | open, classified | Safety and efficacy of dialysis acid concentrate cannot be assured |
| Nov 5, 2025 | Z-0992-2026 | — | open, classified | Safety and efficacy of dialysis acid concentrate cannot be assured |
| Nov 5, 2025 | Z-0990-2026 | — | open, classified | Safety and efficacy of dialysis acid concentrate cannot be assured |
| Jul 27, 2022 | Z-0207-2025 | — | open, classified | Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label. |
| Apr 30, 2020 | Z-2402-2020 | — | terminated | Incorrect labeling of dialysate concentration for hemodialysis. |