FDA.reportPublic FDA data

Vivo 1/2, Vivo 3

Primary DI
07321820072026
Brand
Vivo 1/2, Vivo 3
Company
Breas Medical AB
Model
007202
Catalog number
007202
Device description
Air Inlet Filter, white (5pcs)
Published
2025-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MNSVentilator, Continuous, Non-Life-Supporting
MNTVentilator, Continuous, Minimal Ventilatory Support, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2
MNTSv70 VentilatorAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240778000
K240779000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240778000Vivo 1, Vivo 2Breas Medical AB2024-12-13MNS
K240779000Vivo 3Breas Medical AB2024-12-13MNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07321820072026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07321820072026073218200720267321820072026

GMDN Terms#

Term, Definition table
TermDefinition
Portable electric ventilatorA portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
357007657
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07321820048915Vivo 500048910048912022-06-18
07321820048922Vivo 500048920048922022-06-18
07321820048939Vivo 500048930048932022-06-18
07321820048946Vivo 500048940048942022-06-18
07321820048960Vivo 500048960048962022-06-18
07321820048977Vivo 500048970048972022-06-18
07321820048984Vivo 500048980048982022-06-18
07321820050369Vivo 500050360050362022-06-18
07321820050949Vivo 500050940050942022-06-18
07321820052233Vivo 500052230052232022-06-18
07321820059287Vivo 500059280059282022-06-18
07321822320002Clearo2320002320002026-02-17
07321820104666Clearo Patient Circuit Americas0104660104662025-11-03
05060405720083Clearo2320002320002025-11-03
07321820081691Clearo0081690081692025-11-03
07321820082834Clearo0082830082832025-11-03
07321820090655Clearo0090650090652025-11-03
07321820090662Clearo0090660090662025-11-03
07321820090679Clearo0090670090672025-11-03
07321820106226Clearo Patient Circuit Americas0104660104662025-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012465511Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
09420012480866Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
08401934313389ResScanRESMED CORP.MNS2023-02-24
08401934313389ResScanRESMED CORP.MNT2023-02-24
08401934313396ResScanRESMED CORP.MNT2023-02-24
08401934313396ResScanRESMED CORP.MNS2023-02-24
09420012455000Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455062Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455338Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455727Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012459695Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460295Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460615Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460639Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460738Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460752Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460776Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460790Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
00606959044203Care OrchestratorRespironics, Inc.MNS2020-09-23
00606959044203Care OrchestratorRespironics, Inc.MNT2020-09-23
00606959033344Li Ion Battery, Ventilation, JapanRespironics, Inc.MNS2019-06-05
00606959033306BatteryRespironics, Inc.MNS2019-03-04
00606959038127OmniLab Advanced PlusRespironics, Inc.MNT2017-11-28
09420012436078Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2017-10-13
09420012436092Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2017-10-13
09420012436115Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2017-10-13
09420012436139Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2017-10-13
00606959047464DreamMapperRespironics, Inc.MNT2017-06-21
00606959047471DreamMapperRespironics, Inc.MNS2017-06-21
00606959047488DreamMapperRespironics, Inc.MNS2017-06-21