RPC

Basic Information

• Brand Name: RPC
• Primary DI: 00858293006076
• Version / Model: 480007-FMC-CC
• Catalog Number: 480007-FMC-CC
• Company Name: REPROCESSING PRODUCTS CORPORATION
• Labeler DUNS: 796083392
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-19
• Public Version: 4
• Public Version Date: 2019-08-16
• Public Version Status: Update
• Public Device Record Key: b4549873-d07e-401a-b48c-8e7a65ac53e1

Device Description

K100-0118F Color Card - Fresenius

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSY	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62444	Haemodialysis equipment residual chlorine test strip	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858293006076	GS1

Premarket Submissions

Submission Number	Supplement Number
K090338	000