OratectCheck Oral Fluid Controls OC001

GUDID 00816555020222

Positive and Negative Oral Fluid Controls

BRANAN MEDICAL CORPORATION

Multiple drugs of abuse IVD, calibrator Multiple drugs of abuse IVD, calibrator Multiple drugs of abuse IVD, calibrator

• Primary Device ID: 00816555020222
• NIH Device Record Key: 55a13147-9d38-4faa-b7b2-a290c36e3a14
• Commercial Distribution Discontinuation: 2018-11-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OratectCheck Oral Fluid Controls
• Version Model Number: OC001
• Catalog Number: OC001
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816555020222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103227

FDA Product Code

• DIF: Drug Mixture Control Materials

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: 2018-11-05
• Device Publish Date: 2016-07-29

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