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Vivo 45 LS

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 230000Model Vivo 45 LS/ NIPPY 4+

by Breas Medical AB

Identity

Trade Name
Vivo 45 LS EUDAMEDFDA UDI
Generic Name
Portable electric ventilator FDA UDI
Device Name
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. FDA UDI
Model / Reference
Vivo 45 LS/ NIPPY 4+ EUDAMED
230000 EUDAMED
US FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
230000 FDA UDI
Primary DI / UDI-DI
07321822300004 EUDAMEDFDA UDI
Basic UDI-DI
732182230999AC EUDAMED
510(k) Number
K193586 FDA UDI
FDA Product Code
CBK FDA UDI
NOU FDA UDI
EMDN Code
Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
GMDN Term
Portable electric ventilator FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
868.5895 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Vivo 45 LS by Breas Medical AB — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Breas Medical AB
EUDAMED SRN
SE-MF-000001061

Sources (3)

  • EUDAMED 83ba7f80-3377-4412-b3fb-27076461c7c3 61 fields · synced Oct 5, 2026
  • FDA UDI 5b117907-d4f5-4b07-a558-550ba8ca0ba5 36 fields · synced May 30, 2026
  • FDA 510(k) K193586 1 fields · synced May 18, 2026