mCup®

GUDID 10867802000211

ESCREEN, INC.

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• Primary Device ID: 10867802000211
• NIH Device Record Key: 215000f7-80f3-42d8-8831-4f8f134bf120
• Commercial Distribution Discontinuation: 2019-05-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: mCup®
• Version Model Number: MCP5-001
• Company DUNS: 014079359
• Company Name: ESCREEN, INC.
• Device Count: 25
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867802000214 [Unit of Use]
GS1	10867802000211 [Primary]

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-06
• Device Publish Date: 2016-09-24

On-Brand Devices [mCup®]

• 10867802000211: MCP5-001
• 10867802000266: MCP5A-001
• 10867802000259: MCP11A-001
• 10867802000242: MCP10A-001
• 10867802000235: MCP9A-001
• 10867802000228: MCP7A-001