AlcoBreath Tube AAB1540

GUDID G354AAB15400

Disposable breath alcohol test

Alcopro Inc.

Alcohol breath analyser

• Primary Device ID: G354AAB15400
• NIH Device Record Key: 25e171a1-fcac-4307-b8a6-9593116c1d13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlcoBreath Tube
• Version Model Number: ABT15
• Catalog Number: AAB1540
• Company DUNS: 113044739
• Company Name: Alcopro Inc.
• Device Count: 100
• 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	G354AAB15400 [Unit of Use]
HIBCC	G354AAB15402 [Primary]

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