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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 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bio-Med Devices, Inc. | 40011PE | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFA | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002K2 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001K | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFN | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003EFB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004M | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003AS1 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | MVP-10 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003IB2 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002F60A | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003KB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | MVP-10 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003F | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | MVP-10 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003EF15B | 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. | 2003T | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFE5 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FLB | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 20011PE | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2004B | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001F | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | CROSSVENT | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003KA | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001M | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002FP70 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2002 | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2001T | FDA UDI | Class II | Active |
| Bio-Med Devices, Inc. | 2003FFR | FDA UDI | Class II | Active |
| M-10 Ventilation Monitor | K871139 | FDA 510(k) | Class II | Active |
| Ventilator Test Lung | K800125 | FDA 510(k) | Class II | Active |
| Crossvent-4 Ventilator | K942938 | FDA 510(k) | Class II | Active |
| Mvp-10 Mri Infant Ventilator | K896381 | FDA 510(k) | Class II | Active |
| Et-3 Emergency Transport Ventilator | K823861 | FDA 510(k) | Class II | Active |
| M-2 Oxygen/Temperature Monitor | K871337 | FDA 510(k) | Class II | Active |
| M-1 Pressure Monitor | K871336 | FDA 510(k) | Class II | Active |
| Ic-2a Mri Adult/Pediatric Ventilator | K896380 | FDA 510(k) | Class II | Active |
| Ic-2 Ventilator | K801890 | FDA 510(k) | Class II | Active |
| Cbg Cuff Manometer | K873614 | FDA 510(k) | Class II | Active |
| Programmable Ventilator | K830230 | FDA 510(k) | Class II | Active |
| Promed 38 Sofblu (polymacon) Soft (spherical & Toric) Daily Wear Contact Lens (tinted, Lathe-Cut Form Lens Blank) | K971515 | FDA 510(k) | Class II | Active |
| OxyMinder | K213948 | FDA 510(k) | Class II | Active |
| Ic-5 Ventilator | K813253 | FDA 510(k) | Class II | Active |
| Promed 55-G Soft Daily Wear Contact Lens | K970615 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
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. |