Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips

Primary DI
M17451671
Brand
Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips
Company
SERIM RESEARCH CORPORATION
Model
5167
Catalog number
5167
Device description
SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate. The test also indicates the concentration of residual chlorine (chlorine bleach) remaining in the water used to rinse dialysate lines following disinfection of hemodialysis equipment.
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
MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSYStrip, Test, Reagent, Residuals For Dialysate, DisinfectantGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080712000SERIM HISENSE ULTRA 0.1, PART NUMBER 5167Serim Research Corp.2008-05-06MSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M174516711PackageHIBCC1Not in Commercial Distribution
M17451672PackageHIBCC5In Commercial Distribution
M1745167IN2PackageHIBCC1In Commercial Distribution
M17451671PrimaryHIBCC0
M17451670Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis equipment residual chlorine test stripA sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change and visual comparison to a colour chart, the concentration of residual chlorine in water samples. It is typically used as a means to test whether chlorine has been adequately rinsed from haemodialysis equipment following disinfection. 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

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

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