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Vivo 1/2, Vivo 3

FDA UDIEUDAMED

Class II (US FDA UDI)

by Breas Medical AB

Identity

Trade Name
Vivo 1/2, Vivo 3 FDA UDI
Generic Name
Portable electric ventilator FDA UDI
Device Name
Air Inlet Filter, white (5pcs) FDA UDI
Model / Reference
007202 FDA UDI
Description
Air Inlet Filter, white (5pcs) FDA UDI

Identifiers

Catalog Number
007202 FDA UDI
Primary DI / UDI-DI
07321820072026 FDA UDI
510(k) Number
K240778 FDA UDI
K240779 FDA UDI
FDA Product Code
MNT FDA UDI
MNS 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Portable electric ventilator

Vivo 1/2, Vivo 3 by Breas Medical AB — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Portable electric ventilator.

Cleared under the same submission

K240778 also covers:

K240779 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Breas Medical AB

Sources (2)

  • FDA UDI 74ba1e61-7d50-4680-8fb2-af9c04bb3a73 35 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026