Oxycodone DAU Calibrator, Cutoff Calibrator #1 0243b

GUDID B0760243B0

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

LIN-ZHI INTERNATIONAL, INC.

Oxycodone IVD, calibrator Oxycodone IVD, calibrator

• Primary Device ID: B0760243B0
• NIH Device Record Key: 16bafc1b-4530-4971-b3ee-33c846896be9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxycodone DAU Calibrator, Cutoff Calibrator #1
• Version Model Number: 0243b
• Catalog Number: 0243b
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0760243B0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120763

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: 4
• Public Version Date: 2018-08-24
• Device Publish Date: 2016-07-05

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