FDA.reportPublic FDA data

Mespere

Primary DI
M9833340000101
Brand
Mespere
Company
Mespere LifeSciences Inc
Model
RH-01
Published
2016-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PFANon-Invasive Central Venous Manometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFANon-Invasive Central Venous ManometerCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151776000Central Venous Pressure SystemMespere Lifesciences, Inc.2015-08-12PFA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9833340000101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Venous pressure monitor, invasive detectionAn electrically-powered device designed for continuous or intermittent measurement, display, and recording of a patient's direct central or peripheral venous pressure, or the difference between central and peripheral venous pressure. It is designed to be used with an invasive needle or catheter (not included).

Regulatory Flags#

DUNS number
203147665
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9831101000041Mespere SEN-V20002016-10-06
M9831102000011Mespere DM-102016-10-06
M9831104000021Mespere DS-012016-10-06
M9831104000031Mespere MM-012016-10-06
M9831105000061Mespere PS-012016-10-06
M9831106000021Mespere IS-012016-10-06
M9831107000031Mespere SRA-V20002016-10-06
M9831108000021Mespere IFU-V20002016-10-06
M9831108000031Mespere QG-V20002016-10-06
M9831109000011Mespere OS-012016-10-06
M9831501000021Mespere SEN-NeurOs2019-01-28
M9831507000021Mespere SA-NeurOs2019-01-28
M9831509000011Mespere OS-NeurOs2019-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17290109153060AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VAEITAN MEDICAL LTDPFA2022-05-15
27290109153067AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VAQ-CORE MEDICAL LTDPFA2022-05-15
M9831101000041Mespere Mespere LifeSciences IncPFA2016-10-06
M9831102000011Mespere Mespere LifeSciences IncPFA2016-10-06
M9831104000021Mespere Mespere LifeSciences IncPFA2016-10-06
M9831104000031Mespere Mespere LifeSciences IncPFA2016-10-06
M9831105000061Mespere Mespere LifeSciences IncPFA2016-10-06
M9831106000021Mespere Mespere LifeSciences IncPFA2016-10-06
M9831107000031Mespere Mespere LifeSciences IncPFA2016-10-06
M9831108000021Mespere Mespere LifeSciences IncPFA2016-10-06
M9831108000031Mespere Mespere LifeSciences IncPFA2016-10-06
M9831109000011Mespere Mespere LifeSciences IncPFA2016-10-06