Serim® GUARDIAN™ Blood Leak Test Strips

Primary DI
M17451191
Brand
Serim® GUARDIAN™ Blood Leak Test Strips
Company
SERIM RESEARCH CORPORATION
Model
Blood Leak 50's
Catalog number
5119
Device description
Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during thehemodialysis procedure.
Published
2026-01-29
Public version status
New
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
FJDDetector, Leak, Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJDDetector, Leak, BloodGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012115000SERIM BLOOD LEAK TEST STRIP-2Serim Research Corp.2001-11-30FJD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M17451191PrimaryHIBCC0
M17451190Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system blood leak detectorAn electrically-powered integral unit of a haemodialysis system that detects blood leaks in the effluent side of the dialysate within the system and sounds an alarm if there is blood detected on this non-blood side.

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
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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M17451092Serim® GUARDIAN™ HiSENSE™ Test Kit 510951092016-09-19
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M1745140K2Serim® PyloriTek® Test Kit 05140K05140K2016-09-19
M1745100C1Serim® GUARDIAN™ Residual Chlorine Test Strips 5100C5100C2016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M17451190Serim® GUARDIAN™ Blood Leak Test StripsSERIM RESEARCH CORPORATIONFJD2026-01-29
00858293006175EZ-ChekREPROCESSING PRODUCTS CORPORATIONFJD2017-03-07
00858293006397EZ-ChekREPROCESSING PRODUCTS CORPORATIONFJD2017-03-07
M1745119C1Serim® GUARDIAN™ Blood Leak Test StripsSERIM RESEARCH CORPORATIONFJD2017-02-12
M1745119C2Serim® GUARDIAN™ Blood Leak Test StripsSERIM RESEARCH CORPORATIONFJD2017-02-12
00851575007112SteriChek® Blood Leak Reagent StripsHACH COMPANYFJD2016-10-28
00851575007105SteriChek® Blood Leak Reagent StripsHACH COMPANYFJD2016-10-28
00851575007129SteriChek® Blood Leak Reagent StripsHACH COMPANYFJD2016-10-28