Vivo 65

FDA UDI

Class II (US FDA UDI)

by Breas Medical AB

Identity

Trade Name: Vivo 65 FDA UDI
Generic Name: Portable electric ventilator FDA UDI
Device Name: Continuos, Ventilator, Home Use FDA UDI
Model / Reference: US FDA UDI
Description: Continuos, Ventilator, Home Use FDA UDI

Identifiers

Catalog Number: 224516 FDA UDI
Primary DI / UDI-DI: 07321822240003 FDA UDI
510(k) Number: K160481 FDA UDI
FDA Product Code: NOU FDA UDI
GMDN Term: Portable electric ventilator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Portable electric ventilator

Vivo 65 by Breas Medical AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K160481 also covers:

Vivo 45 LS, Vivo 65 — BREAS MEDICAL, INC.
Vivo 45 LS, Vivo 65 — BREAS MEDICAL, INC.
Vivo 65 — BREAS MEDICAL, INC.
Vivo 45 LS, Vivo 65 — Breas Medical AB
Vivo 65 — Breas Medical AB

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Breas Medical AB

Sources (1)

FDA UDI dd1af633-e9b2-459f-9562-d3e6cad4c0e6 36 fields · synced May 30, 2026