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. - 00813841020317 Catalog Number : 2003FFN

Device Description : Air / Oxygen Blender low flow with flowmeters

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020324 Catalog Number : 2003FFQ

Device Description : Air / Oxygen Blender low flow with flowmeters

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020331 Catalog Number : 2003FL

Device Description : Air / Oxygen Blender low 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. - 00813841020348 Catalog Number : 2003FLA

Device Description : Air / Oxygen Blender low 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. - 00813841020355 Catalog Number : 2003FLEU

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. - 00813841020362 Catalog Number : 2003K

Device Description : Air / Oxygen Blender low flow switching

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020379 Catalog Number : 2003KC

Device Description : Air / Oxygen Blender low flow for CV

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020386 Catalog Number : 2003KJ

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. - 00813841020393 Catalog Number : 2003M

Device Description : Air / Oxygen Blender low flow MR-conditional

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020409 Catalog Number : 2004F7015

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

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