BIO-MED DEVICES, INC.

Address:61 SOUNDVIEW RD,GUILFORD,CT,06437,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Accessory To Continuous Ventilator (Respirator) (MOD) (10)

Premarket Exempt

No Yes

Clear

Bio-Med Devices, Inc. - 00813841020416 Catalog Number : 2004F7015A

Device Description : Air / Oxygen Blender with 3 ports and 2 flowmeters

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020423 Catalog Number : 2004M

Device Description : Air / Oxygen Blender with 3 ports MR-conditional

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020430 Catalog Number : 2003H

Device Description : Air / Oxygen Blender low flow

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020447 Catalog Number : 2003IB1

Device Description : Air / Oxygen Blender low flow for International Biomedical

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020454 Catalog Number : 2003IB2

Device Description : Air / Oxygen Blender low flow for International Biomedical

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020461 Catalog Number : 2002F70X

Device Description : Air / Oxygen Blender high flow with flowmeter

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020478 Catalog Number : 2003FLEUX

Device Description : Air / Oxygen Blender low flow with EU flowmeter

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020485 Catalog Number : 2001T

Device Description : Air / Oxygen Blender high / low flow Tri-Anim

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020492 Catalog Number : 2003T

Device Description : Air / Oxygen Blender low flow Tri-Anim

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020508 Catalog Number : 2002F60A

Device Description : Air / Oxygen Blender high flow with flowmeter

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

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