Checkpoint

Basic Information

• Brand Name: Checkpoint
• Primary DI: G354CCP082001
• Version / Model: CP08
• Catalog Number: CCP08200
• Company Name: Alcopro Inc.
• Labeler DUNS: 113044739
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-09-22
• Public Version: 1
• Public Version Date: 2022-09-30
• Public Version Status: New
• Public Device Record Key: 8e1f7d80-f65d-4117-81f4-ea5354db7895

Device Description

Disposable breath alcohol test

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	862.3050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36041	Alcohol breath analyser	A portable, battery-powered instrument intended to measure and document alcohol concentrations in human breath at the point-of-care.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	G354CCP082002	HIBCC		50	In Commercial Distribution
Primary	G354CCP082001	HIBCC
Package	G354CCP082003	HIBCC		100	In Commercial Distribution
Unit of Use	G354CCP082000	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K102225	000