FDA.reportPublic FDA data

Serim® GUARDIAN™ Peracetic Acid Test Strips

Primary DI
M17451061
Brand
Serim® GUARDIAN™ Peracetic Acid Test Strips
Company
SERIM RESEARCH CORPORATION
Model
5106
Catalog number
5106
Device description
SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing concentrates such as Renalin® Cold Sterilant, PerAldecide™, Puristeril® 340, Peracidin™ and Micro-X®.
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M17451062PackageHIBCC6In Commercial Distribution
M17451061PrimaryHIBCC0
M17451060Unit 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
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
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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