Oral-Eze Collection System

GUDID 00884883012653

Microgenics Corporation

Drug-testing specimen collection kit IVD

• Primary Device ID: 00884883012653
• NIH Device Record Key: 6c2f96cd-6d9a-4159-9a06-1f8bf66c60ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oral-Eze Collection System
• Version Model Number: 96100-050
• Company DUNS: 122153799
• Company Name: Microgenics 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884883012653 [Primary]

FDA Product Code

• PJD: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-12

On-Brand Devices [Oral-Eze Collection System]

• 00884883012653: 96100-050
• 00884883012585: 96100-500