PreKnow

GUDID 00857275007490

Cocaine COC Single Drug Test Dip Card

IDUN SOLUTIONS LLC

Cocaine/cocaine metabolite IVD, kit, immunochromatographic test (ICT), rapid Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical

• Primary Device ID: 00857275007490
• NIH Device Record Key: ff1f34b9-4bf2-46a3-98ab-9f6fb2dc4497
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreKnow
• Version Model Number: 21114061610308
• Company DUNS: 080651010
• Company Name: IDUN SOLUTIONS 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857275007377 [Package]; Package: [25 Units]; In Commercial Distribution
GS1	00857275007490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153050

FDA Product Code

• DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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: 2018-09-03
• Device Publish Date: 2018-08-02

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