DEVICE: ECO™ Cup (00841824103092)

Device Identifier (DI) Information

ECO™ Cup
WECCUP354
In Commercial Distribution
WECCUP354
W.H.P.M. INC.
00841824103092
GS1

25
602085672 *Terms of Use
DOA 5 in 1 Test ECO Cup, 25Pcs/Box Clia Waived COC/mAMP/OPI/PCP/THC
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
Yes
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

2a11e618-9763-4a95-a848-5b614b9907a8
March 29, 2018
2
October 18, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00841824103146 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE