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Sign in to claim this brandPyrames, Inc.
US
Last updated May 25, 2026
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- —
- DUNS Number
- 080935399
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Boppli | 51-0007 | FDA UDI | Class II | Active |
| Boppli | 53-0003 | FDA UDI | Class II | Active |
| Boppli | 54-0002 | FDA UDI | Class II | Active |
| Boppli Infant Blood Pressure Monitor | K223873 | FDA 510(k) | Class II | Active |
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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 24, 2025 | Z-1508-2025 | — | open, classified | Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot. |