Oratect Oral Fluid Drug Screen Device HM15

GUDID 00816555020215

MET50/THC40/COC20/AMP50/OPI40/PCP10 Oral Fluid Test Kit

BRANAN MEDICAL CORPORATION

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• Primary Device ID: 00816555020215
• NIH Device Record Key: 4b823273-6f94-4340-a2e4-1446e3e10cc2
• Commercial Distribution Discontinuation: 2018-10-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Oratect Oral Fluid Drug Screen Device
• Version Model Number: HM15
• Catalog Number: HM15
• Company DUNS: 184347305
• Company Name: BRANAN MEDICAL CORPORATION
• 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: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com
• Phone: 1-866-468-3287
• Email: info@brananmedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816555020215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103227

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: 4
• Public Version Date: 2018-10-02
• Device Publish Date: 2016-07-29

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