BREEZE® 2 1490A

GUDID 50301931490010

Control Solution - Low, 1 x 2.5 mL

ASCENSIA DIABETES CARE US INC.

Glucose IVD, control
Primary Device ID50301931490010
NIH Device Record Key56ab0df8-e356-4fc1-b5e9-2644d3717087
Commercial Distribution Discontinuation2018-01-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBREEZE® 2
Version Model Number1490A
Catalog Number1490A
Company DUNS080028910
Company NameASCENSIA DIABETES CARE US INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone18003488100
Emailsupport@contournext.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100301931490015 [Package]
Contains: 10301931490012
Package: carton [1 Units]
Discontinued: 2018-01-25
Not in Commercial Distribution
NDC/NHRIC0193-1490-01 [Secondary]
GS110301931490012 [Primary]
GS140301931490013 [Package]
Contains: 00301931490015
Package: in.shipper/sm.case [12 Units]
Discontinued: 2018-01-25
Not in Commercial Distribution
GS150301931490010 [Package]
Contains: 40301931490013
Package: out.shipper/lg.case [32 Units]
Discontinued: 2018-01-25
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-09-16

On-Brand Devices [BREEZE® 2]

40301931468500Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
40301931467503Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
00301931466218Blood Glucose Test Strips. Sold in a carton of 100 Test Strips (10 Discs).
40301931465509Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
50301931491017Control Solution - High, 1 x 2.5 mL
50301931490010Control Solution - Low, 1 x 2.5 mL
50301931489014Control Solution - Normal, 1 x 2.5 mL

Trademark Results [BREEZE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BREEZE
BREEZE
98442875 not registered Live/Pending
Tempur World, LLC
2024-03-11
BREEZE
BREEZE
98418473 not registered Live/Pending
Breeze Aviation Group, Inc.
2024-02-23
BREEZE
BREEZE
98354188 not registered Live/Pending
eSIM Go Limited
2024-01-12
BREEZE
BREEZE
98212948 not registered Live/Pending
Rheem Manufacturing Company
2023-10-06
BREEZE
BREEZE
98018566 not registered Live/Pending
Societe des Produits Nestle S.A.
2023-05-30
BREEZE
BREEZE
97860099 not registered Live/Pending
Breeze Ball, LLC
2023-03-28
BREEZE
BREEZE
97777102 not registered Live/Pending
Alleva Medical Limited
2023-02-01
BREEZE
BREEZE
97739923 not registered Live/Pending
Yardi Systems, Inc.
2023-01-03
BREEZE
BREEZE
97534734 not registered Live/Pending
Red Wing Shoe Company, Inc.
2022-08-04
BREEZE
BREEZE
97497618 not registered Live/Pending
QADM LLC
2022-07-11
BREEZE
BREEZE
97492585 not registered Live/Pending
Opsis Health, Inc.
2022-07-07
BREEZE
BREEZE
97444459 not registered Live/Pending
Residential Warranty Services, Inc.
2022-06-06

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