eScreen eCup 201

GUDID 10867802000280

The eScreen eCup® is a patented 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: 10867802000280
• NIH Device Record Key: 2ff88f09-7c04-40d3-b3de-83f36b86e363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eScreen eCup
• Version Model Number: eCup
• Catalog Number: 201
• Company DUNS: 014079359
• Company Name: ESCREEN, INC.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867802000283 [Unit of Use]
GS1	10867802000280 [Primary]

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-05-24
• Device Publish Date: 2016-09-16

Devices Manufactured by ESCREEN, INC.

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• 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: 2021-05-24The eScreen eCup® is a patented 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.
• 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