BREEZE® 2

Basic Information

• Brand Name: BREEZE® 2
• Primary DI: 20301931466212
• Version / Model: 1466A
• Catalog Number: 1466A
• Company Name: ASCENSIA DIABETES CARE US INC.
• Labeler DUNS: 080028910
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-06-19
• Public Version: 4
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: 524e23fa-7c15-4a33-843a-5fa89c0c329e
• Distribution End Date: 2018-06-27

Device Description

Blood Glucose Test Strips. Sold in a carton of 100 Test Strips (10 Discs).

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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00301931466218	GS1	carton	10	Not in Commercial Distribution	2018-06-27
Package	10301931466215	GS1	blister/pouch	1	Not in Commercial Distribution	2018-06-27
Primary	20301931466212	GS1
Secondary	0193-1466-21	NDC/NHRIC
Unit of Use	00301931466010	GS1
Package	40301931466216	GS1	shipper/case	16	Not in Commercial Distribution	2018-06-27

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K062347	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight. Do not use after expiration date.
• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit