FDA.reportPublic FDA data

Vivo 50

Primary DI
07321820050369
Brand
Vivo 50
Company
Breas Medical AB
Model
005036
Catalog number
005036
Device description
Remote Alarm incl cable 10m
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
07321820050369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07321820050369073218200503697321820050369

GMDN Terms#

Term, Definition table
TermDefinition
Nurse call system alarmAn electronic device intended to provide an audible sound and/or a visual display, typically coloured flashing lights or scrolling text, to notify a medical professional that (urgent) assistance is needed by a patient. It may be in the form of dome lights, basic visual display screens, and/or beeping devices which are triggered by manual or automatic alert activators (e.g., bedside push-button, ambulatory fall sensor, bed occupancy sensor) [not included]; it may function independently or as a component of a nurse call system via the healthcare facility hardwired or wireless network.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Meter

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

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
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
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