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) (5) Ventilator, Non-Continuous (Respirator) (BZD) (3) Ventilator, Continuous, Facility Use (CBK) (1)

Premarket Exempt

No Yes

Clear

Breas iSleep 20 System - 07321822050008 Catalog Number : 205000

Device Description : Ventilator Non-continuous (Respirator)

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Breas iSleep 20+ system - 07321822060007 Catalog Number : 206000

Device Description : Ventilator Non-continuous (Respirator)

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Breas iSleep 20i system - 07321822070006 Catalog Number : 207000

Device Description : Ventilator Non-continuous (Respirator)

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Vivo 50 - 07321822150005 Catalog Number : 215000

Device Description : Continuous, Ventilator, Home Use

Device Class :

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Vivo 50 - 07321822150166 Catalog Number : 215016

Device Description : Continuous, Ventilator, Home Use

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Vivo 50 - 07321822151163 Catalog Number : 215116

Device Description : Continuous, Ventilator, Home Use

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Vivo 65 - 07321822240003 Catalog Number : 224516

Device Description : Continuos, Ventilator, Home Use

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321822300004 Catalog Number : 230000

Device Description : The Vivo 45 LS Ventilator is a portable, microprocessor-controlled turbine based The Vivo 45 LS Ventilator is a portable, microprocessor-controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation. Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers. Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support. The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery. The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.

Device Class :

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

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