Norfentanyl DAU Calibrator, Cutoff Calibrator 0313

GUDID B07603130

5 mL/bottle. Concentration: 5 ng/mL of Norfentanyl.

LIN-ZHI INTERNATIONAL, INC.

Fentanyl IVD, calibrator

• Primary Device ID: B07603130
• NIH Device Record Key: a56500bd-db7f-4f2a-8c78-3a75be0492cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norfentanyl DAU Calibrator, Cutoff Calibrator
• Version Model Number: 0313
• Catalog Number: 0313
• Company DUNS: 840839190
• Company Name: LIN-ZHI INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
HIBCC	B07603130 [Primary]

FDA Product Code

• DLJ: Calibrators, Drug Specific

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-03
• Device Publish Date: 2019-03-26

Devices Manufactured by LIN-ZHI INTERNATIONAL, INC.

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