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) (9) Ventilator, Continuous, Facility Use (CBK) (1)

Premarket Exempt

No Yes

Clear

Bio-Med Devices, Inc. - 00813841020003 Catalog Number : 2010

Device Description : Infant Ventilator, pneumatic

Device Class : 2

Duns Number: 116167966

Premarket Exempt : Yes

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020010 Catalog Number : 2003GE

Device Description : Air / Oxygen Blender low flow for GE

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020034 Catalog Number : 2001

Device Description : Air / Oxygen Blender high / low flow

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020041 Catalog Number : 2002

Device Description : Air / Oxygen Blender high flow

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020058 Catalog Number : 2003

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. - 00813841020065 Catalog Number : 2004

Device Description : Air / Oxygen Blender with 3 ports

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020072 Catalog Number : 2000K

Device Description : Air / Oxygen Blender mid flow

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

Bio-Med Devices, Inc. - 00813841020089 Catalog Number : 2000KM

Device Description : Air / Oxygen Blender mid 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. - 00813841020096 Catalog Number : 2001F

Device Description : Air / Oxygen Blender high / 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. - 00813841020102 Catalog Number : 2001FEU

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

Device Class : 2

Duns Number: 116167966

Premarket Exempt : No

Product Code : MOD

Prescription Use : Yes

Device Count : 1

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