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) (7) Stand, Infusion (FOX) (2)

Premarket Exempt

No Yes

Clear

Ventilator Trolley - 07321820067619 Catalog Number : 006761

Device Description : Trolley Mounting Bracket, Vivo 45 LS

Device Class : 1

Duns Number: 357007657

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321820070640 Catalog Number : 007064

Device Description : Air Bypass, Vivo 45 LS

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321820070671 Catalog Number : 007067

Device Description : PC Software Vivo 45 LS

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321820071036 Catalog Number : 007103

Device Description : Filter, air inlet filter fine, Qty 5

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 5

Vivo 45 LS - 07321820071043 Catalog Number : 007104

Device Description : Filter, air inlet filter coarse, Qty 5

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 5

Vivo 45 LS - 07321820071050 Catalog Number : 007105

Device Description : Filter, cooling air, Qty 5

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 5

Vivo 50 - 07321820072194 Catalog Number : 007219

Device Description : Power Cord US - 12 ft

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Ventilator Trolley - 07321820073849 Catalog Number : 007384

Device Description : Ventilator Trolley (base unit)

Device Class : 1

Duns Number: 357007657

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321820075553 Catalog Number : 007555

Device Description : Lightweight Bag

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321820076543 Catalog Number : 007654

Device Description : Pilot Line Connector

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

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