Norbuprenorphine DAU Control, Level 1 Control A68824

GUDID 00869335000235

5mL/bottle. Concentration: 7 ng/mL of Norbuprenorphine.

LIN-ZHI INTERNATIONAL, INC.

Buprenorphine IVD, control

• Primary Device ID: 00869335000235
• NIH Device Record Key: 8ad7e764-8097-4b61-a218-580e252e3e8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norbuprenorphine DAU Control, Level 1 Control
• Version Model Number: A68824
• Catalog Number: A68824
• Company DUNS: 840839190
• Company Name: LIN-ZHI INTERNATIONAL, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869335000235 [Primary]

FDA Product Code

• LAS: Drug Specific Control Materials

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-15
• Device Publish Date: 2016-07-05

On-Brand Devices [Norbuprenorphine DAU Control, Level 1 Control]

• 00869335000235: 5mL/bottle. Concentration: 7 ng/mL of Norbuprenorphine.
• B07602720: 5mL/bottle. Concentration: 3 ng/mL of Norbuprenorphine.