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US
Last updated September 17, 2026
About
BIO-MED manufactures some of the most reliable and accurate air-oxygen and NeO2 Blenders for ventilators on the market for the ICU, portablel applications, and more
From the manufacturer's own website. Source
Information
- Country
- US
- Address
- 61 SOUNDVIEW RD, GUILFORD, CT, 06437
- Website
- biomeddevices.com
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- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003952420
- DUNS Number
- —
Catalogue (152)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tv-100 | K173973 | FDA 510(k) | Class II | Active |
| OxyMinder Pro (10310) | K251245 | FDA 510(k) | Class II | Active |
Related Companies
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Authorities
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FDA Recalls (11)
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 |
|---|---|---|---|---|
| Oct 19, 2010 | Z-0971-2011 | — | terminated | Breathing circuit may disconnect between the adapter adjacent tubing cuff |
| Oct 19, 2010 | Z-0972-2011 | — | terminated | Breathing circuit may disconnect between the adapter adjacent tubing cuff |
| Dec 6, 2004 | Z-0425-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0427-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0428-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0429-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0430-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0424-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0423-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Dec 6, 2004 | Z-0426-05 | — | terminated | Adapters may be occluded potentially preventing inhalation |
| Nov 7, 2003 | Z-0300-04 | — | terminated | Two way relief valve may fail to activate at the low negative pressure of -3cm H2O. |