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) (10) Ventilator, Continuous, Facility Use (CBK) (6)

Premarket Exempt

Yes No

Clear

Vivo 50 - 07321820048960 Catalog Number : 004896

Device Description : Remote alarm cable 10m

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Vivo 50 - 07321820048977 Catalog Number : 004897

Device Description : Remote alarm cable 25m

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Vivo 50 - 07321820048984 Catalog Number : 004898

Device Description : Remote alarm cable 50m

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Vivo 50, Vivo 65 - 07321820048991 Catalog Number : 004886

Device Description : External battery cable 24V DC

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 50, Vivo 65, Vivo 45 LS - 07321820049011 Catalog Number : 004901

Device Description : 12-24 V DC Converter

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 50, VIvo 65 - 07321820049097 Catalog Number : 004909

Device Description : Patient Air Inlet filter (grey, washable), 5 pcs

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 5

Vivo 50, VIvo 65 - 07321820049103 Catalog Number : 004910

Device Description : Patient Air Inlet filter (white, disposable), 10 pcs

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 10

Vivo 50, VIvo 65 - 07321820049394 Catalog Number : 004939

Device Description : Carry bag

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 50, Vivo 65, Vivo 45 LS - 07321820050321 Catalog Number : 005032

Device Description : Oxygen adapter low pressure

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 50 - 07321820050369 Catalog Number : 005036

Device Description : Remote Alarm incl cable 10m

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

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