AccessGUDID - DEVICE: BREEZE® 2 (20301931467509)

GUDID

Device Identifier (DI) Information

Brand Name: BREEZE® 2
Version or Model: 1467A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 56853239
Company Name: ASCENSIA DIABETES CARE US INC.

Primary DI Number: 20301931467509
Issuing Agency: GS1
Commercial Distribution End Date: January 10, 2018
Device Count: 10
Labeler D-U-N-S® Number*: 080028910 *Terms of Use

Device Description: Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGA	Glucose Oxidase, Glucose
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep out of direct sunlight. Do not use after expiration date.
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 05e1af1c-c8f4-49fd-8dbd-a3ff010f6547
Public Version Date: November 06, 2024
Public Version Number: 5
DI Record Publish Date: September 16, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
40301931467503	24	00301931467505	2018-01-10	Not in Commercial Distribution	shipper/case
00301931467505	5	10301931467502	2018-01-10	Not in Commercial Distribution	carton
10301931467502	1	20301931467509	2018-01-10	Not in Commercial Distribution	blister/pouch