Easy@Home OXY Single Drug Screen Test (10 tests kit)

Basic Information

• Brand Name: Easy@Home OXY Single Drug Screen Test (10 tests kit)
• Primary DI: 00855944007703
• Version / Model: EDOX-114-10
• Company Name: EASY HEALTHCARE CORPORATION
• Labeler DUNS: 080278407
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-08-02
• Public Version: 5
• Public Version Date: 2022-07-25
• Public Version Status: Update
• Public Device Record Key: 5cc8f476-39f6-4717-b7e8-5e7b169394c2

Device Description

Easy@Home Single Drug Screen Test ; 10 tests kit; OXY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test 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
Package	10855944007700	GS1	Carton	90	In Commercial Distribution
Primary	00855944007703	GS1
Unit of Use	90855944007706	GS1

Premarket Submissions

Submission Number	Supplement Number
K133968	000