BluRapids™ TNR MMC12MOP

GUDID 00850011007099

BluRapids CLIA Waived Drug Cup; 12 Panel BluRapids AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA

MERCEDES MEDICAL, LLC

Tricyclic antidepressant IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00850011007099
• NIH Device Record Key: 51221d49-68b3-4358-b35b-0a242b5ebf9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BluRapids™
• Version Model Number: TNR MMC12MOP
• Catalog Number: TNR MMC12MOP
• Company DUNS: 834472680
• Company Name: MERCEDES MEDICAL, 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: false

Customer Support Contacts

• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com
• Phone: 8003312716
• Email: sherry.harris@mercedesmedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away fron direct sunlight, mositure, and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away fron direct sunlight, mositure, and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away fron direct sunlight, mositure, and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away fron direct sunlight, mositure, and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away fron direct sunlight, mositure, and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away fron direct sunlight, mositure, and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011007099 [Primary]
GS1	10850011007096 [Package]; Package: Inner pack [25 Units]; In Commercial Distribution
GS1	20850011007093 [Package]; Contains: 10850011007096; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153050

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

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: 2018-11-08
• Device Publish Date: 2016-08-15

On-Brand Devices [BluRapids™]

• 00850011007112: BluRapids CLIA Waived Drug Cup; 13 Panel AMP,BAR,BZO,COC,MET,MDMA,OPI300,MTD,OXY,PCP,TCA,THC wit
• 00850011007105: BluRapids CLIA Waived Drug Cup; 13 Panel AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/TH
• 00850011007099: BluRapids CLIA Waived Drug Cup; 12 Panel BluRapids AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/
• 00850011007082: BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC
• 00850011007075: BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/OPI2000/OXY/PCP/THC
• 00850011007068: BluRapids CLIA Waived Drug Cup; 12 panel AMP/ BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI-300/OXY/ PCP/THC
• 00850011007044: BluRapids CLIA Waived Drug Cup; 6 Panel with Adulterants BZO/COC/MET/OPI/OXY/THC
• 20850011007031: BlueRapids CLIA Waived Drug Cup; 6 Panel AMP/BZO/COC/MET/OPI2000/THC
• 10850011007027: BlueRapids CLIA Waived Drug Cup; 5-Panal AMP/COC/PCP/OPI2000/THC
• 20850011007017: BluRapids CLIA Waived Drug Cup; 5-Panel AMP/COC/MET/OPI/THC