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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 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bio-Med Devices, Inc. | 2003FF2B | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFFP | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFE1 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003U | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFAB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FLEU | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2000KM | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003MB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001FB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002K | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001C | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003KJ | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FF15 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFE1A | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004MB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003KC | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003I | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002M | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFEA | 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. | 2003K | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFEU | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | TV-100 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002F70A | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004F7015EU | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFG | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FF1 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003GE | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FF1B | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFEUA | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2000K | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003DA | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFH | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003Q | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003TR | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003AJ1 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003H | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | IC-2A | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002F70X | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004F7015X | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FLEUX | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFK | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FL | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002F70D | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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. |