DrugSmart Cup 61230D

GUDID 00859144006221

THC/COC/OPI2000/AMP/MET/PCP/MDMA/BAR/BZO/MTD/PPX/OXY drugs of abuse test cup

Twin Spirit Inc.

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

• Primary Device ID: 00859144006221
• NIH Device Record Key: 267cdc42-7180-4380-9cfa-1624e45cacc5
• Commercial Distribution Discontinuation: 2018-06-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DrugSmart Cup
• Version Model Number: 61230D
• Catalog Number: 61230D
• Company DUNS: 617011296
• Company Name: Twin Spirit Inc.
• 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: false

Customer Support Contacts

• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859144006221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113501

FDA Product Code

• JXN: Enzyme Immunoassay, Propoxyphene

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: 2020-01-28
• Device Publish Date: 2016-09-01

On-Brand Devices [DrugSmart Cup]

• 00859144006238: AMP/OPI300/COC/THC/MET/BZO/BAR/MTD/OXY/MDMA/BUP drugs of abuse test cup
• 00859144006221: THC/COC/OPI2000/AMP/MET/PCP/MDMA/BAR/BZO/MTD/PPX/OXY drugs of abuse test cup
• 00859144006214: PCP/AMP/THC/COC150/MET500/BAR/BZO/OPI300/OXY/MDMA with adulteration pH/CR/OX drugs of abuse test
• 00859144006207: THC/COC/AMP/MET/OPI drugs of abuse test cup
• 00859144006191: THC/COC/AMP/PCP/OPI drugs of abuse test cup
• 00859144006184: THC/COC/AMP/BAR/OPI drugs of abuse test cup
• 00859144006177: THC/COC/AMP/BZO/OPI/MET drugs of abuse test cup
• 00859144006160: THC/COC/AMP/MET/OPI/OXY drugs of abuse test cup
• 00859144006153: THC/COC/OPI/AMP/MET/BZO/MTD/OXY/BUP drugs of abuse test cup
• 00859144006146: COC/THC/BZO/AMP/BAR/OPI2000/MET/MDMA/TCA/PCP drugs of abuse tes cup
• 00859144006139: THC/COC/AMP/PCP/OPI/MET/BAR/BZO/MTD/OXY drugs of abuse test cup
• 00859144006122: THC/COC/BAR/BZO/MET/OPI300/MTD/PPX/OXY/MDMA drugs of abuse test cup
• 00859144006115: THC/COC/BAR/BZO/MET/OPI300/AMP/PPX/OXY/MDMA drugs of abuse test cup
• 00859144006108: THC/COC/AMP/BAR/BZO/MET/OPI300/PPX/OXY/BUP drugs of abuse test cup
• 00859144006092: THC/COC/AMP/MET/BAR/BZO/OPI/PCP/MDMA/MTD drugs of abuse test cup
• 00859144006085: THC/COC/AMP/MET/BAR/BZO/OPI/PCP/PPX/MTD drugs of abuse test cup
• 00859144006078: COC/THC/MET/OPI/AMP/MDMA/BAR/BZO/MTD/PPX/OXY/BUP drugs of abuse test cup
• 00859144006061: COC/THC/MET/OPI/AMP/BAR/BZO/MTD/PCP/PPX/OXY/BUP drugs of abuse test cup
• 00859144006054: THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAI
• 00859144006047: THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
• 00859144006030: THC, COC, OPI300, AMP, MET, PCP, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
• 00859144006023: THC, COC, OPI300, AMP, MET, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
• 00859144006016: THC, COC, OPI, AMP, MET, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
• 00859144006009: THC, COC, OPI, MET, BZO, OXY drugs of abuse test cup (CLIA WAIVED)