Serim® GUARDIAN™ Residual Peroxide Test Strips

Primary DI
M17451052
Brand
Serim® GUARDIAN™ Residual Peroxide Test Strips
Company
SERIM RESEARCH CORPORATION
Model
5105
Catalog number
5105
Device description
Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of peroxide remaining in dialysate lines and dialyzers after disinfection with peracetic acid/peroxide-based disinfectants.
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIFDialyzer Reprocessing System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIFDialyzer Reprocessing SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K900341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900341000SERIM RESIDUAL PEROXIDE/RENALIN TEST KITSerim Research Corp.1990-07-11LIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M17451052PackageHIBCC6In Commercial Distribution
M17451051PrimaryHIBCC0
M17451050Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection solution test stripA sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of the active ingredient in a device disinfectant and/or sterilant solution after preparation, to ensure disinfectant/sterilant properties. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
605151018
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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M17451051Serim® GUARDIAN™ Residual Peroxide Test Strips 510551052016-09-08
M17451091Serim® GUARDIAN™ HiSENSE™ Test Kit 510951092016-09-19
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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
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
M1745100C1Serim® GUARDIAN™ Residual Chlorine Test Strips 5100C5100C2016-08-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10677964007979Renalin Residual Test StripsMEDIVATORS INC.LIF2018-07-09
10677964009119Perassay 500 Peracetic Acid Test StripsMEDIVATORS INC.LIF2018-07-09
00898021000235PeraSidualAngelini Pharma Inc.LIF2017-05-23
00898021000242PeraChekAngelini Pharma Inc.LIF2017-05-23
00382830034456NATUS NEUROLOGY NATUS NEUROLOGY INCORPORATEDLIF2017-03-17
00858293006120Micro-XREPROCESSING PRODUCTS CORPORATIONLIF2017-03-07
00851575007044SteriChek® Peroxide Reagent StripsHACH COMPANYLIF2016-09-23
00851575007075SteriChek® Residual Peroxide Reagent StripsHACH COMPANYLIF2016-09-23
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M17451051Serim® GUARDIAN™ Residual Peroxide Test Strips SERIM RESEARCH CORPORATIONLIF2016-09-08
M17451121Serim® GUARDIAN™ Residual Formaldehyde Test Strips SERIM RESEARCH CORPORATIONLIF2016-09-08
00898021000037Maky 21.1Angelini Pharma Inc.LIF2016-08-29