OratectCheck Oral Fluid Controls OC001

GUDID 00816555020222

Positive and Negative Oral Fluid Controls

BRANAN MEDICAL CORPORATION

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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