FDA.reportPublic FDA data

EZ-Chek

Primary DI
00858293006397
Brand
EZ-Chek
Company
REPROCESSING PRODUCTS CORPORATION
Model
5119
Catalog number
5119
Device description
Blood Leak Test Strip K100-0114 2/pack
Published
2017-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K123805000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123805000E-Z CHEK BLOOD LEAK TEST STRIPSReprocessing Products Corp2013-03-20FJD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858293006397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858293006397008582930063978582930063970858293006397

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis treatment kitA collection of sterile and disposable/consumable devices intended to be used to prepare for and perform a haemodialysis treatment with a haemodialysis system. It typically consists of tubing, haemodialysis dialysers, dialysate concentrates, and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796083392
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858293006939Peracidin0818942026-07-24
00858293006946Peracidin0818962026-07-24
00858293006328EZ-ChekK100-0101BK100-0101B2017-03-07
00858293006915Accu-ReadBP00-22012025-04-02
00858293006120Micro-XK100-0105K100-01052017-03-07
00858293006922Micro-XMX-32122023-02-20
00858293006458Luer Fitting FemaleBF00-00102019-08-30
00858293006465Luer Fitting MaleBF00-00112019-08-30
00858293006496Black Tubing, NaturalBT00-01002019-08-30
00858293006502Black Tubing, PVCBT00-01032019-08-30
00858293006908Spiral Coil Tubing, Trans BluePU532-8TD0PU532-8WT02021-05-17
00858293006373E-Z Chek5116AK100-01172017-03-07
00858293006380EZ-Chek5100AK100-0101B2017-03-07
00858293006885Spiral Coil Tubing, Clear1W-013-102021-05-17
00858293006892Spiral Coil Tubing, Trans RedPU532-8WD02021-05-17
00858293006861Sani-lok Blood Port Barrier Adaptor7000-10502021-05-13
00858293006878Sani-lok Blood Port Barrier Adaptor7000-10502021-05-13
00858293006700Spiral Tubing, Trans Red1W-013-252019-08-30
00858293006717Spirial Tubing, Trans Blue1W-013-272019-08-30
00858293006724Spiral Coil Tubing Clear1W-025-102019-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M17451191Serim® GUARDIAN™ Blood Leak Test StripsSERIM RESEARCH CORPORATIONFJD2026-01-29
M17451190Serim® GUARDIAN™ Blood Leak Test StripsSERIM RESEARCH CORPORATIONFJD2026-01-29
00858293006175EZ-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