Norbuprenorphine DAU Control, Level 2 Control

Basic Information

• Brand Name: Norbuprenorphine DAU Control, Level 2 Control
• Primary DI: 00869335000259
• Version / Model: A68825
• Catalog Number: A68825
• Company Name: LIN-ZHI INTERNATIONAL, INC.
• Labeler DUNS: 840839190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-20
• Public Version: 5
• Public Version Date: 2018-10-15
• Public Version Status: Update
• Public Device Record Key: c8ccbdab-7e40-4c4c-973b-a9f14b4715cb

Device Description

5mL/bottle. Concentration: 13 ng/mL of Norbuprenorphine.

Device Characteristics

• Single Use: No
• 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
LAS	Drug Specific Control Materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42760	Buprenorphine IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of buprenorphine in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00869335000259	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius