Coastline Explorer Cup X13-DT13A

GUDID 00868754000208

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

COASTLINE MEDICAL MANAGEMENT, LLC

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

• Primary Device ID: 00868754000208
• NIH Device Record Key: df1142d8-3ab5-43f9-a61c-de9d2cda03c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coastline Explorer Cup
• Version Model Number: X13-DT13A
• Catalog Number: X13-DT13A
• Company DUNS: 079629844
• Company Name: COASTLINE MEDICAL MANAGEMENT, LLC
• Device Count: 1
• 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: true

Customer Support Contacts

• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx
• Phone: 1-888-508-8266
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868754000208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122633

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-15
• Device Publish Date: 2016-09-01