AccessGUDID - DEVICE: BREEZE® 2 (10301931491019)

GUDID

Device Identifier (DI) Information

Brand Name: BREEZE® 2
Version or Model: 1491A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 81007218
Company Name: ASCENSIA DIABETES CARE US INC.

Primary DI Number: 10301931491019
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 080028910 *Terms of Use

Device Description: Control Solution - High, 1 x 2.5 mL

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:	No
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?
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)
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: 00347610-621a-42bd-95fb-2ebe52ac71de
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
50301931491017	32	40301931491010	2018-01-31	Not in Commercial Distribution	out.shipper/lg.case
40301931491010	12	00301931491012	2018-01-31	Not in Commercial Distribution	in.shipper/sm.case
00301931491012	1	10301931491019	2018-01-31	Not in Commercial Distribution	carton