Oral-Eze

Basic Information

• Brand Name: Oral-Eze
• Primary DI: 00859952006024
• Version / Model: 95376
• Catalog Number: 95376
• Company Name: CAPITOL VIAL, INC.
• Labeler DUNS: 151639481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-10
• Public Version: 3
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: c1c552ea-fb17-4440-8b3f-fa1919861b6f

Device Description

ORAL-EZE PUBLIX BAG KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
PJD	Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38868	Drug-testing specimen collection kit IVD	A covered receptacle and other associated materials/tools, available for use in the home and clinical settings, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other in vitro diagnostic investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859952006024	GS1
Unit of Use	00859952006048	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect from prolonged exposure to direct sunlight
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius