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Sign in to claim this brandFIREFLY MEDICAL, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 320 E Vine Dr Ste 315, Fort Collins, CO, 80524
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3011390406
- DUNS Number
- —
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ivea | 600S | FDA UDI | Class I | Active |
| Oxygen (O2) Tank Booster Accessory for IVEA | 16289 | FDA UDI | Class I | Active |
Related Companies
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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 |
|---|---|---|---|---|
| Aug 24, 2017 | Z-3239-2017 | — | terminated | The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit. |
| Nov 1, 2016 | Z-0767-2017 | — | terminated | The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble. |