BREAS MEDICAL, INC.

Address:16 Esquire Road,N Billerica,MA,01862,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

Ventilator, Non-Continuous (Respirator) (BZD) (5)

Premarket Exempt

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HUMAN DESIGN MEDICAL - 00859477004000 Catalog Number : HD60-1010

Device Description : Ventilator, Non Continuous Respirator with Battery Source

Device Class : 2

Duns Number: 079296736

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

HUMAN DESIGN MEDICAL - 00859477004017 Catalog Number : HD60-1005

Device Description : Ventilator, Non Continuous Respirator

Device Class : 2

Duns Number: 079296736

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

HUMAN DESIGN MEDICAL - 00859477004116 Catalog Number : HD60-7010

Device Description : Battery Source for Ventilator, Non Continuous Respirator

Device Class : 2

Duns Number: 079296736

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

HUMAN DESIGN MEDICAL - 00859477004123 Catalog Number : HD60-1007

Device Description : Ventilator, Non Continuous Respirator

Device Class : 2

Duns Number: 079296736

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

HUMAN DESIGN MEDICAL - 00859477004161 Catalog Number : HD60-1017

Device Description : Ventilator, Non Continuous Respirator with Battery Source

Device Class : 2

Duns Number: 079296736

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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