FDA.reportPublic FDA data

RPC

Primary DI
00858293006038
Brand
RPC
Company
REPROCESSING PRODUCTS CORPORATION
Model
K100-0118
Catalog number
K100-0118
Device description
Ultra-Low Total Chlorine Test Strips
Published
2017-01-19
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
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
K090338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090338000ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINEReprocessing Products Corp2009-05-08MSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858293006035PackageGS1100In Commercial Distribution
00858293006038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085829300603510858293006035
00858293006038008582930060388582930060380858293006038

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.

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
00860006352165Chlorine Sentinel IINelson Environmental Technologies IncMSY2025-04-16
00860006352103Basic Chlorine SentinelNelson Environmental Technologies IncMSY2022-07-06
00898021000242PeraChekAngelini Pharma Inc.MSY2017-05-23
00858293006052RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
00858293006328EZ-ChekREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
10858293006059RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
00858293006083RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
00858293006113Micro-XREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
10858293006325EZ-ChekREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
00858293006380EZ-ChekREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
00858293006045RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
10858293006035RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
30858293006046RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
00858293006069RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
00858293006076RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
00858293006090EZ-ChekREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
00858293006106EZ-ChekREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
00851575007020SteriChek® Residual Chlorine Reagent StripsHACH COMPANYMSY2016-11-23
00851575007051SteriChek® Total Chlorine Test KitHACH COMPANYMSY2016-11-23
00851575007068Sterichek® Total Chlorine Test Kit RefillHACH COMPANYMSY2016-11-23
00851575007150SteriChek® Peracetic Acid Reagent StripsHACH COMPANYMSY2016-09-23
M17451671Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips SERIM RESEARCH CORPORATIONMSY2016-09-08
M1745167IN2Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips SERIM RESEARCH CORPORATIONMSY2016-09-08