Easy@Home Ketone Test Strips (20 Pack)

Basic Information

• Brand Name: Easy@Home Ketone Test Strips (20 Pack)
• Primary DI: 00810038631431
• Version / Model: EZR-101
• Catalog Number: EZR-101-20(P)
• Company Name: EASY HEALTHCARE CORPORATION
• Labeler DUNS: 080278407
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-02-17
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: bb058838-5420-47b9-b8d0-2dd96312c1e7

Device Description

Easy@Home Ketone Test Strips (20 Pack)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	862.1435	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54519	Urine ketone IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for ketones within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810038631431	GS1
Unit of Use	30810038631432	GS1

Premarket Submissions

Submission Number	Supplement Number
K170587	000