FDA.reportPublic FDA data

Vivo 1/2

Primary DI
07321822270000
Brand
Vivo 1/2
Company
Breas Medical AB
Model
Vivo 1
Catalog number
227500
Device description
Ventilator, Continuous, Non-Life-Supporting
Published
2025-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNSVentilator, Continuous, Non-Life-Supporting
NOUContinuous, Ventilator, Home Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2
NOUContinuous, Ventilator, Home UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240778000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07321822270000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07321822270000073218222700007321822270000

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

Contacts#

Phone, Email table
PhoneEmail
855-436-8724supportUS@breas.com

Regulatory Flags#

DUNS number
357007657
Device count
1
Serial number
true
Manufacturing date on label
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
08401934313389ResScanRESMED CORP.MNS2023-02-24
08401934313396ResScanRESMED CORP.MNS2023-02-24
00606959049024DreamMapper Web (DM)Respironics, Inc.MNS2020-10-16
00606959049031DreamMapper Web (EMEA)Respironics, Inc.MNS2020-10-16
00606959049048DreamMapper Web (APAC)Respironics, Inc.MNS2020-10-16
00606959049055DreamMapper Mobile App Android (DMM)Respironics, Inc.MNS2020-10-16
00606959049086DreamMapper App iOSRespironics, Inc.MNS2020-10-16
00606959049093DreamMapper App iOS (EMEA)Respironics, Inc.MNS2020-10-16
00606959049109DreamMapper App iOS (APAC)Respironics, Inc.MNS2020-10-07
00606959044203Care OrchestratorRespironics, Inc.MNS2020-09-23
00606959028869TrilogyRespironics, Inc.NOU2020-02-26
00606959028883TrilogyRespironics, Inc.NOU2020-02-26
00606959028890TrilogyRespironics, Inc.NOU2020-02-26
00606959028913TrilogyRespironics, Inc.NOU2020-02-26
00606959028920TrilogyRespironics, Inc.NOU2020-02-26
00606959028937TrilogyRespironics, Inc.NOU2020-02-26
00606959028944TrilogyRespironics, Inc.NOU2020-02-26
00606959038868TrilogyRespironics, Inc.NOU2020-02-26
00606959033344Li Ion Battery, Ventilation, JapanRespironics, Inc.MNS2019-06-05
00606959047587Trilogy EvoRespironics, Inc.NOU2019-05-08
00606959033306BatteryRespironics, Inc.MNS2019-03-04
00606959048324Trilogy 100Respironics, Inc.MNS2018-05-18
00606959048362EncoreAnywhereRespironics, Inc.MNS2017-10-10
00606959048379EncoreAnywhereRespironics, Inc.MNS2017-10-10
00606959048386EncoreAnywhereRespironics, Inc.MNS2017-10-10
17290013641936Continuous VentilatorFLIGHT MEDICAL INNOVATIONS LTDNOU2017-10-06
17290013641950Continuous VentilatorFLIGHT MEDICAL INNOVATIONS LTDNOU2017-10-06
17290013641967Continuous VentilatorFLIGHT MEDICAL INNOVATIONS LTDNOU2017-10-06
00606959048508DreamMapper Web (DM)Respironics, Inc.MNS2017-10-04
00606959048515DreamMapper Web (EMEA)Respironics, Inc.MNS2017-10-04