OratectCheck Oral Fluid Controls

Basic Information

• Brand Name: OratectCheck Oral Fluid Controls
• Primary DI: 00816555020222
• Version / Model: OC001
• Catalog Number: OC001
• Company Name: BRANAN MEDICAL CORPORATION
• Labeler DUNS: 184347305
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-29
• Public Version: 4
• Public Version Date: 2018-11-05
• Public Version Status: Update
• Public Device Record Key: 55a13147-9d38-4faa-b7b2-a290c36e3a14
• Distribution End Date: 2018-11-02

Device Description

Positive and Negative Oral Fluid Controls

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DIF	Drug Mixture Control Materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55460	Multiple drugs of abuse IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816555020222	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K103227	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – -10 Degrees Celsius