FDA.reportPublic FDA data

MesaLabs

Primary DI
M985065003210
Brand
MesaLabs
Company
MESA LABORATORIES, INC.
Model
06.500321
Catalog number
06.500321
Device description
pHoenix Dialysate Meter
Published
2015-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FIZMeter, Conductivity, Non-Remote

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIZMeter, Conductivity, Non-RemoteGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955298000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955298000PHOENIX DIALYSATE METERAutomata Medical Instrumentation, Inc.1996-02-29FIZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9850600030PackageHIBCC3In Commercial Distribution
M9850600390PackageHIBCC3In Commercial Distribution
M985065003210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-parameter device testerA battery-powered electronic device designed to measure two or more parameters (e.g., temperature, conductivity, pressure, pH, flow) to calibrate or test a medical device (e.g., haemodialysis equipment, anaesthesia machine, suction system, ophthalmic laser). It typically consists of a hand-held electronic box with appropriate connections and a digital display; dedicated measuring devices (e.g., probe, sensor, electrode, buffer solution) are typically included. It is not dedicated to a specific clinical discipline and is intended to be used by a professional in a professional setting (e.g., clinical engineering).

Regulatory Flags#

DUNS number
102530326
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M98551000T1Dual Spore Strips - Test10e5/10e65-1000T2017-10-20
M985CIDHI1Mesa Labs Dry Heat Indicator LabelsCI-DHICI-DHI2016-11-30
M985CISSIX1ProChem SSE EmulatorCI-SSIXCI-SSIX2016-11-30
M985CIBDTLF0Bowie Dick Type TestProChemCI-BDTLF2016-10-24
M9850141001Spore Strip10e41-41002025-01-15
M9850161001Spore Strip - EO/Dry Heat10e61-61002025-01-15
M9850341001Spore Strip10e43-41002025-01-15
M9850351001Spore Strip Steam & Chemiclave10e53-51002025-01-15
M9850361001Spore Strip Steam & Chemiclave10e63-61002025-01-15
M985051000C1Dual Spore Strips - Control10e5, 10e65-1000C2025-01-15
M985051000T1Dual Spore Strips - Test10e5, 10e65-1000T2025-01-15
M985055100T1Dual Spore Strip - Test10e5, 10e65-5100T2025-01-15
M9850141000Spore Strip10e41-41002025-01-15
M9850161000Spore Strip - EO/Dry Heat10e61-61002025-01-15
M9850341000Spore Strip10e43-41002025-01-15
M9850351000Spore Strip Steam & Chemiclave10e53-51002025-01-15
M9850361000Spore Strip Steam & Chemiclave10e63-61002025-01-15
M985051000C0Dual Spore Strips - Control10e5, 10e65-1000C2025-01-15
M985051000T0Dual Spore Strips - Test10e5, 10e65-1000T2025-01-15
M985HFY5201017950 HealthFirst Mail-In Spore Testing Service, 52 TestsHF-Y52HF-Y522024-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M98536000010MesaLabsMESA LABORATORIES, INC.FIZ2020-09-14
EIBPHDM97BH1001HDM97IBP Medical GmbHFIZ2016-12-01
EIBPHDM97BH151HDM97IBP Medical GmbHFIZ2016-12-01
EIBPHDM97BH301HDM97IBP Medical GmbHFIZ2016-12-01
EIBPHDM97BH501HDM97IBP Medical GmbHFIZ2016-12-01
EIBPHDM97BH51HDM97IBP Medical GmbHFIZ2016-12-01
EIBPHDM97BL1HDM97IBP Medical GmbHFIZ2016-12-01
EIBPHDM97BM1HDM97IBP Medical GmbHFIZ2016-12-01
EIBPHDM97BN1HDM97IBP Medical GmbHFIZ2016-12-01
EIBPHDM97BO1HDM97IBP Medical GmbHFIZ2016-12-01
EIBPHDM97BP1HDM97IBP Medical GmbHFIZ2016-12-01
EIBPHDM97BQ1HDM97IBP Medical GmbHFIZ2016-12-01
M98536000000MesaLabsMESA LABORATORIES, INC.FIZ2016-05-16
M985035003210MesaLabsMESA LABORATORIES, INC.FIZ2015-10-28