FDA.reportPublic FDA data

Vivo 50

Primary DI
07321820059287
Brand
Vivo 50
Company
Breas Medical AB
Model
005928
Catalog number
005928
Device description
PC Software
Published
2022-06-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOUContinuous, Ventilator, Home Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOUContinuous, Ventilator, Home UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123144000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123144000VIVO 50Ge Healthcare, Breas Medical AB2013-06-18NOU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07321820059287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07321820059287073218200592877321820059287

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment clinical data interfacing softwareAn application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
357007657
Device count
1
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
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
07321820104727GCX- Vivo 45 Series Trolley0104720104722025-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.NOU2025-12-02
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.NOU2025-08-06
00850018761383VOCSN Passive ValveVentec Life Systems, Inc.NOU2024-12-02
00619498291410AstralRESMED PTY LTDNOU2023-07-26
00855573007822VOCSNVentec Life Systems, Inc.NOU2023-06-30
07290017856728Roll Stand for use with ventilatorsFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-06
07290017856698 Test Lung KitFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856704 Test Lung Quick Release KitFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856711Quick Release KitFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856735Ventilator 3 Section Arm with ExFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856742Carrying CaseFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856759Rail Mount KitFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856766O2 KitFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07321820021857Vivo 50, Vivo 65, Vivo 45 LSBreas Medical ABNOU2022-06-18
07321820035229Vivo 45 LSBreas Medical ABNOU2022-06-18
07321820045594Vivo 50, VIvo 65Breas Medical ABNOU2022-06-18
00855573007761VOCSNVentec Life Systems, Inc.NOU2022-04-12
00855573007785VOCSNVentec Life Systems, Inc.NOU2022-04-12
00850018761178VOCSN Power SupplyVentec Life Systems, Inc.NOU2022-03-23
00850018761154VOCSNVentec Life Systems, Inc.NOU2021-04-30
00850018761161VOCSNVentec Life Systems, Inc.NOU2021-04-30
00850018761130VOCSNVentec Life Systems, Inc.NOU2021-03-03
00850018761116VOCSNVentec Life Systems, Inc.NOU2021-02-23
00850018761109VOCSN High Flow KitVentec Life Systems, Inc.NOU2021-02-23
00606959055483Trilogy EvoRespironics, Inc.NOU2021-02-12
00606959062863Care Orchestrator EssenceRespironics, Inc.NOU2021-02-09
00606959051980Trilogy EvoRespironics, Inc.NOU2021-01-22
00606959060449Care Orchestrator Essence SoftwareRespironics, Inc.NOU2021-01-22
00619498003259Astral 100RESMED PTY LTDNOU2021-01-08
00619498003266Astral 150RESMED PTY LTDNOU2021-01-08