AccessGUDID - DEVICE: Coastline Explorer Cup (00868754000208)

GUDID

Device Identifier (DI) Information

Brand Name: Coastline Explorer Cup
Version or Model: X13-DT13A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X13-DT13A
Company Name: COASTLINE MEDICAL MANAGEMENT, LLC

Primary DI Number: 00868754000208
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079629844 *Terms of Use

Device Description: THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100 w/ Cr,Ni,pH,Bl,S.G. drugs of abuse test cup

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):	Yes
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
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs
DJR	Enzyme Immunoassay, Methadone
DIS	Enzyme Immunoassay, Barbiturate
JXM	Enzyme Immunoassay, Benzodiazepine
DKZ	Enzyme Immunoassay, Amphetamine
DJC	Thin Layer Chromatography, Methamphetamine
DJG	Enzyme Immunoassay, Opiates
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LDJ	Enzyme Immunoassay, Cannabinoids

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122633	000

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df1142d8-3ab5-43f9-a61c-de9d2cda03c6
Public Version Date: June 10, 2022
Public Version Number: 7
DI Record Publish Date: September 01, 2016