eCUP™

Basic Information

• Brand Name: eCUP™
• Primary DI: 10860429001012
• Version / Model: E&I eCUP™
• Catalog Number: 206
• Company Name: ESCREEN, INC.
• Labeler DUNS: 014079359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-04-24
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: c8ddeeb0-38f6-467d-bc17-8ad0b7b9c2dc

Device Description

The eScreen eCUP™ is a patented human urine collection device designed to allow for rapid, under-seal screening. The eCUP™’s lid contains several embedded reagent test strips that are sensitive to the five-test SAMHSA (Substance Abuse and Mental Health Services Administration) profile cutoff levels. The lid’s test strips also detect and provide adulteration panels for pH, creatinine, and nitrites. When the eCUP™ is placed into the eREADER™ device, its test strips are digitally screened for the presence or absence of drugs of abuse.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3870	2
PVG	Test, Morphine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3640	2
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3610	2
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3250	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
Primary	10860429001012	GS1
Unit of Use	00860429001015	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius