RPC K100-0118F

GUDID 30858293006046

Ultra-Low Total Chlorine Test Strips - Fresenius

REPROCESSING PRODUCTS CORPORATION

Haemodialysis equipment residual chlorine test strip
Primary Device ID30858293006046
NIH Device Record Key1e11d95e-80fb-4b26-818f-b4005c5973fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameRPC
Version Model NumberK100-0118F
Catalog NumberK100-0118F
Company DUNS796083392
Company NameREPROCESSING PRODUCTS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858293006045 [Primary]
GS110858293006042 [Package]
Contains: 00858293006045
Package: package [100 Units]
In Commercial Distribution
GS120858293006049 [Package]
Contains: 10858293006042
Package: box [1 Units]
In Commercial Distribution
GS130858293006046 [Package]
Contains: 20858293006049
Package: carton [22 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-16
Device Publish Date2017-01-19

On-Brand Devices [RPC]

00858293006083K100-0118BX Color Card - Baxter
00858293006076K100-0118F Color Card - Fresenius
00858293006069K100-0118 Color Card
10858293006059Ultra-Low Total Chlorine Test Strips - Baxter
30858293006046Ultra-Low Total Chlorine Test Strips - Fresenius
10858293006035Ultra-Low Total Chlorine Test Strips
20858293006018Injectable Catheter Cap
20858293006001Recirculation Connector

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