FDA.reportPublic FDA data

Mespere

Primary DI
M9831101000041
Brand
Mespere
Company
Mespere LifeSciences Inc
Model
SEN-V2000
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
M9831101000041PrimaryHIBCC0

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, by means of an indwelling catheter and a pressure manometer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9833340000101Mespere RH-012016-10-06
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
M9833340000101Mespere 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