First Sign® FSCCUPCO-25P

GUDID 00817763022558

DOA Single Test Cup, 25Pcs/Box, CLIA Waived; First Sign for Hemosure, CLIA Waived, COC

W.H.P.M. INC.

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• Primary Device ID: 00817763022558
• NIH Device Record Key: 248ec129-a8a9-4f14-8b28-e4a0eb2c0df5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: First Sign®
• Version Model Number: FSCCUPCO-25
• Catalog Number: FSCCUPCO-25P
• Company DUNS: 602085672
• Company Name: W.H.P.M. INC.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817763022558 [Unit of Use]
GS1	00817763022565 [Primary]

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: 2020-03-09
• Device Publish Date: 2020-02-28

On-Brand Devices [First Sign®]

• 00841824103177: DOA Single Test Dipcard, 25Pcs/Box Clia Waived THC
• 00841824101968: DOA 5 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/COC/mAMP/MOR/THC
• 00817763022558: DOA Single Test Cup, 25Pcs/Box, CLIA Waived; First Sign for Hemosure, CLIA Waived, COC
• 00817763022787: DOA 9 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure, CLIA Waived AMP/BARB/BUP/BZO/COC/mAMP/M