eCUP™ 206

GUDID 10860429001012

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.

ESCREEN, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10860429001012
• NIH Device Record Key: c8ddeeb0-38f6-467d-bc17-8ad0b7b9c2dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eCUP™
• Version Model Number: E&I eCUP™
• Catalog Number: 206
• Company DUNS: 014079359
• Company Name: ESCREEN, INC.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com
• Phone: 800-881-0722
• Email: clientservice@escreen.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860429001015 [Unit of Use]
GS1	10860429001012 [Primary]

FDA Product Code

• PVJ: Test, Cannabinoid, Employment And Insurance Testing, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-04
• Device Publish Date: 2020-04-24

Devices Manufactured by ESCREEN, INC.

• 10867802000228 - mCup®: 2021-05-24
• 10867802000235 - mCup®: 2021-05-24
• 10867802000242 - mCup®: 2021-05-24
• 10867802000259 - mCup®: 2021-05-24
• 10867802000266 - mCup®: 2021-05-24
• 10867802000273 - xCupTM: 2021-05-24 The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, poin
• 10867802000280 - eScreen eCup: 2021-05-24 The eScreen eCup® is a patented urine collection device designed to allow for rapid, under-seal screening. The eCup’s lid con
• 00860429001022 - eREADER™: 2020-05-04 The eScreen eREADER™ is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providin