FDA.reportPublic FDA data

Serim® GUARDIAN™

Primary DI
M1745116B1
Brand
Serim® GUARDIAN™
Company
SERIM RESEARCH CORPORATION
Model
5116B
Catalog number
5116B
Device description
Serim® GUARDIAN™ BICARB pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.
Published
2016-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNVStrip, Dialysate Ph Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNVStrip, Dialysate Ph IndicatorGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945491000SERIM(TM) BICARB PH REAGENT STRIPSSerim Research Corp.1995-02-01MNV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M1745116B2PackageHIBCC5Not in Commercial Distribution
M1745116B1PrimaryHIBCC0
M1745116B0Unit of UseHIBCC0

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-542-4670customerservice@serim.com

Regulatory Flags#

DUNS number
605151018
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M17452120Serim® GUARDIAN™ Quick Dip Residual Chlorine Test Strips 521252122026-03-30
M17451051Serim® GUARDIAN™ Residual Peroxide Test Strips 510551052016-09-08
M17451091Serim® GUARDIAN™ HiSENSE™ Test Kit 510951092016-09-19
M1745119C1Serim® GUARDIAN™ Blood Leak Test Strips5119C5119C2017-02-12
M17451211Serim® DISINTEK™ OPA Test Strips 512151212016-09-08
M1745140K1Serim® PyloriTek® Test Kit 05140K05140K2016-09-19
M17451671Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips 516751672016-09-08
M1745100A1Serim® GUARDIAN™ Residual Chlorine Test Strips5100A5100A2016-08-29
M17451052Serim® GUARDIAN™ Residual Peroxide Test Strips 510551052016-09-08
M17451092Serim® GUARDIAN™ HiSENSE™ Test Kit 510951092016-09-19
M1745119C2Serim® GUARDIAN™ Blood Leak Test Strips5119C5119C2017-02-12
M17451212Serim® DISINTEK™ OPA Test Strips 512151212016-09-08
M1745136A1Serim® DISINTEK™ GTA 1.5% Test Strips 5136A5136A2016-09-08
M1745116A1Serim® GUARDIAN™ Bicarb pH II Test Strips 5116A5116A2016-09-19
M17451061Serim® GUARDIAN™ Peracetic Acid Test Strips 510651062016-09-08
M17451221Serim® PeriScreen™ Test Strips 512251222016-09-08
M17451191Serim® GUARDIAN™ Blood Leak Test StripsBlood Leak 50's51192026-01-29
M17451121Serim® GUARDIAN™ Residual Formaldehyde Test Strips 511251122016-09-08
M17451190Serim® GUARDIAN™ Blood Leak Test StripsBlood Leak 50's51192026-01-29
M1745140K2Serim® PyloriTek® Test Kit 05140K05140K2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858293006137EZ-ChekREPROCESSING PRODUCTS CORPORATIONMNV2017-03-07
00858293006144EZ-ChekREPROCESSING PRODUCTS CORPORATIONMNV2017-03-07
00858293006151EZ-ChekREPROCESSING PRODUCTS CORPORATIONMNV2017-03-07
00858293006168EZ-ChekREPROCESSING PRODUCTS CORPORATIONMNV2017-03-07
00858293006373E-Z ChekREPROCESSING PRODUCTS CORPORATIONMNV2017-03-07
00851575007143Sterichek® BiCarb pH Reagent StripsHACH COMPANYMNV2016-10-28
M1745116A1Serim® GUARDIAN™ Bicarb pH II Test Strips SERIM RESEARCH CORPORATIONMNV2016-09-19