NexScreen Drug Screen Cup with SVT ND-60505N-3A

GUDID 00858984006248

AMP500/COC150/OPI2000/PCP25/THC50/(OX/pH/SG)

NEXSCREEN, LLC

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

• Primary Device ID: 00858984006248
• NIH Device Record Key: e62cbfce-db8a-4b90-817b-eade0bbde5ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexScreen Drug Screen Cup with SVT
• Version Model Number: ND-60505N-3A
• Catalog Number: ND-60505N-3A
• Company DUNS: 031433133
• Company Name: NEXSCREEN, 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: false
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858984006248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-12
• Device Publish Date: 2018-10-10

On-Brand Devices [NexScreen Drug Screen Cup with SVT]

• 00858984006248: AMP500/COC150/OPI2000/PCP25/THC50/(OX/pH/SG)
• 00858984006224: AMP500/COC150/MET500/OPI2000/THC50/(OX/pH/SG)