Norbuprenorphine DAU Calibrator, High Calibrator A68830

GUDID 00869335000280

5mL/bottle. Concentration: 100 ng/mL of Norbuprenorphine.

LIN-ZHI INTERNATIONAL, INC.

Buprenorphine IVD, calibrator

• Primary Device ID: 00869335000280
• NIH Device Record Key: 2b522e5c-7802-4994-9224-1de471e9a0bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norbuprenorphine DAU Calibrator, High Calibrator
• Version Model Number: A68830
• Catalog Number: A68830
• 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	00869335000280 [Primary]

FDA Product Code

• DLJ: Calibrators, Drug Specific

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 Calibrator, High Calibrator]

• 00869335000280: 5mL/bottle. Concentration: 100 ng/mL of Norbuprenorphine.
• B07602790: 5mL/bottle. Concentration: 75 ng/mL of Norbuprenorphine.