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Sign in to claim this brandBio-Med Devices, Inc.
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
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003952420
- DUNS Number
- —
Catalogue (152)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bio-Med Devices, Inc. | 20011NPE | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | IC-2A | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | IC-2A | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | MVP-10 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FLA | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | MVP-10 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003AJ3 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004F7015A | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFQ | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003B | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003AS | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003J | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003IB1 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FF | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 10300 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001FEU | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003C | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004I | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | MVP-10 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 21471 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | MVP-10 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003AJ2 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003D | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004F7015 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002F70 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 80018PE | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003M | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFJ | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FF15B | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFEUC | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001KB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 10301 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001B | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002F70B | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003EF1B | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001MB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003P | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
Not available yet.
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. |