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) (10)

Premarket Exempt

Yes No

Clear

Vivo 45 LS - 07321820062652 Catalog Number : 006265

Device Description : Click-In Battery

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 65 - 07321820063420 Catalog Number : 006342

Device Description : Remote Start/Stop

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 50, VIvo 65 - 07321820063444 Catalog Number : 006344

Device Description : Protective Cover (replaces 004938)

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS, Vivo 65 - 07321820063482 Catalog Number : 006348

Device Description : Remote Alarm w. ODU 10m cable

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS, Vivo 65 - 07321820063499 Catalog Number : 006349

Device Description : Remote Alarm w. ODU 25m cable

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS, Vivo 65 - 07321820063598 Catalog Number : 006359

Device Description : Remote alarm cable, 10 m

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS, Vivo 65 - 07321820063604 Catalog Number : 006360

Device Description : Remote alarm cable, 25 m

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS, Vivo 65 - 07321820063611 Catalog Number : 006361

Device Description : Remote alarm cable, 50 m

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS, Vivo 65 - 07321820063628 Catalog Number : 006362

Device Description : Nurse Call Cable NC, 10 KOhm

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

Vivo 45 LS, Vivo 65 - 07321820063635 Catalog Number : 006363

Device Description : Nurse Call Cable NO, 10 KOhm

Device Class : 2

Duns Number: 357007657

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : Yes

Device Count : 1

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