AlcoBreath Tube AAB0820

GUDID G354AAB08202

Disposable breath alcohol test

Alcopro Inc.

Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser

• Primary Device ID: G354AAB08202
• NIH Device Record Key: 4b730cce-073d-4426-9a85-207d1d8f3f05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlcoBreath Tube
• Version Model Number: ABT08
• Catalog Number: AAB0820
• Company DUNS: 113044739
• Company Name: Alcopro Inc.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G354AAB08200 [Unit of Use]
HIBCC	G354AAB08201 [Primary]
HIBCC	G354AAB08202 [Package]; Contains: G354AAB08201; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102225

FDA Product Code

• DJZ: Devices, Breath Trapping, Alcohol

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: 2022-09-30
• Device Publish Date: 2022-09-22

On-Brand Devices [AlcoBreath Tube]

• G354AAB15400: Disposable breath alcohol test
• G354AAB15202: Disposable breath alcohol test
• G354AAB08400: Disposable breath alcohol test
• G354AAB08202: Disposable breath alcohol test