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Sign in to claim this brandTURNCARE, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 230 West Parkway, Pompton Plains, NJ, 07444
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3013682457
- DUNS Number
- —
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Guardian | GS-TB | FDA UDI | Class II | Active |
| Guardian | GS-SBS-76-1 | FDA UDI | Class II | Active |
| Guardian | GS-2.5-C | FDA UDI | Class II | Active |
| Guardian | GS-SBS-76 | FDA UDI | Class II | Active |
| Guardian | GS-EN-BD-76 | FDA UDI | Class II | Active |
| Guardian | GS-2.5-EN-ST-70 | FDA UDI | Class II | Active |
| Guardian | GS-2.5-EN-PT-70 | FDA UDI | Class II | Active |
| Guardian | GS-2.5-EN-BD-76 | FDA UDI | Class II | Active |
| Guardian | GS-EN-ST-70 | FDA UDI | Class II | Active |
| Guardian | GS-C | FDA UDI | Class II | Active |
| Guardian | GS-EN-PT-70 | FDA UDI | 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 (2)
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 1, 2023 | Z-1967-2025 | — | open, classified | A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy. |
| Aug 10, 2023 | Z-1968-2025 | — | open, classified | A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy. |