AccessGUDID - DEVICE: eScreen eCup (10867802000280)

GUDID

Device Identifier (DI) Information

Brand Name: eScreen eCup
Version or Model: eCup
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 201
Company Name: ESCREEN, INC.

Primary DI Number: 10867802000280
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 014079359 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDJ	Enzyme Immunoassay, Cannabinoids
LCM	Enzyme Immunoassay, Phencyclidine
DJG	Enzyme Immunoassay, Opiates
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LAF	Gas Chromatography, Methamphetamine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2ff88f09-7c04-40d3-b3de-83f36b86e363
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 16, 2016