EZ-Chek

Basic Information

• Brand Name: EZ-Chek
• Primary DI: 00858293006151
• Version / Model: K100-0104
• Catalog Number: K100-0104
• Company Name: REPROCESSING PRODUCTS CORPORATION
• Labeler DUNS: 796083392
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-07
• Public Version: 4
• Public Version Date: 2019-08-16
• Public Version Status: Update
• Public Device Record Key: 3bea7e90-ecbc-4066-af8b-f0b40436152e

Device Description

0 -14 pH Test Strips

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNV	Strip, Dialysate Ph Indicator	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58093	Haemodialysis treatment kit	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858293006151	GS1

Premarket Submissions

Submission Number	Supplement Number
K101750	000