Breas Medical AB

Breas Medical AB

Address:FORETAGSVAGEN 1,MOLNLYCKE Vastra Gotaland,SE

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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

Continuous, Ventilator, Home Use (NOU) (8) Ventilator, Continuous, Facility Use (CBK) (4) Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT) (1) Set, Tubing And Support, Ventilator (W Harness) (BZO) (1)

Premarket Exempt

No Yes

Clear

Vivo 50, Vivo 65, Vivo 45 LS - 07321820021857 Catalog Number : 002185

Device Description : Memory Card Reader

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321820035229 Catalog Number : 003522

Device Description : Power Cord US

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

HA01 - 07321820035304 Catalog Number : 003530

Device Description : Respiratory Gas Humidifier

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vivo Series - 07321820044269 Catalog Number : 004426

Device Description : Swivel Leakage Port

Device Class : 1

Duns Number: 357007657

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

Vivo 50, VIvo 65 - 07321820045594 Catalog Number : 004559

Device Description : Click-On Battery

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 50, Vivo 65 - 07321820048861 Catalog Number : 004886

Device Description : USB Cable A-B

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 50 - 07321820048915 Catalog Number : 004891

Device Description : Nurse Call Cable NO

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Vivo 50 - 07321820048922 Catalog Number : 004892

Device Description : Nurse Call Cable NC

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Vivo 50 - 07321820048939 Catalog Number : 004893

Device Description : Nurse Call Cable NO, 10 KOhm

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Vivo 50 - 07321820048946 Catalog Number : 004894

Device Description : Nurse call cable NC, 10K Ohm

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

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