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) Set, Tubing And Support, Ventilator (W Harness) (BZO) (1) Stand, Infusion (FOX) (1)

Premarket Exempt

No Yes

Clear

Vivo 65 - 07321820055234 Catalog Number : 005523

Device Description : Dual Limb Insert, disposable, Adult

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 65 - 07321820055258 Catalog Number : 005525

Device Description : Dual Limb insert, Paediatric

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 50 - 07321820059287 Catalog Number : 005928

Device Description : PC Software

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321820060146 Catalog Number : 006014

Device Description : Carry bag

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321820060672 Catalog Number : 006067

Device Description : Protective Cover

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo Series - 07321820060931 Catalog Number : 006093

Device Description : MPV circuit 2 pcs

Device Class : 1

Duns Number: 357007657

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 2

Ventilator Trolley - 07321820060955 Catalog Number : 006095

Device Description : MPV Arm

Device Class : 1

Duns Number: 357007657

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321820061723 Catalog Number : 006172

Device Description : FiO2 Sensor

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321820061792 Catalog Number : 006179

Device Description : PtcCO2 cable Sentec

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS - 07321820061808 Catalog Number : 006180

Device Description : PtcCO2 cable Radiometer

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

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