Oral-Eze Collection System

GUDID 00884883012585

Microgenics Corporation

Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD Drug-testing specimen collection kit IVD

Primary Device ID	00884883012585
NIH Device Record Key	b8494e81-ea5b-4a82-9f54-09db0d60c429
Commercial Distribution Status	In Commercial Distribution
Brand Name	Oral-Eze Collection System
Version Model Number	96100-500
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	00884883012585 [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