CONTOUR® NEXT 7309

GUDID 40301937357501

Blood Glucose Test Strips - 50 Test Strips.

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use
Primary Device ID40301937357501
NIH Device Record Key51ba452e-e4f7-4f2a-834f-3b1080f20d56
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONTOUR® NEXT
Version Model Number7309
Catalog Number7309
Company DUNS080028910
Company NameASCENSIA DIABETES CARE US INC.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone18003488100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com
Phone+1(800)348-8100
Emailsupport@contournext.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use after expiration date.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100301937309014 [Unit of Use]
GS100301937309502 [Package]
Contains: 10301937309509
Package: carton [1 Units]
In Commercial Distribution
NDC/NHRIC0193-7309-50 [Secondary]
GS110301937309509 [Primary]
GS140301937309500 [Package]
Contains: 00301937309502
Package: case [24 Units]
In Commercial Distribution
GS140301937357501 [Package]
Contains: 00301937309502
Package: case [24 Units]
Discontinued: 2016-08-25
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZOArtificial Pancreas Device System, Threshold Suspend

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 Date2016-08-25

On-Brand Devices [CONTOUR® NEXT]

40301939697018Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabete
40301937379015Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood gl
40301937377011Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood gl
40301937283350Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 1030193731025
10301937313100Blood Glucose Test Strips - 10 Test Strips.
40301939737219Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 tes
40301939736502Blood Glucose Test Strips - 50 Test Strips.
40301939735253Blood Glucose Test Strips - 25 Test Strips.
40301937357501Blood Glucose Test Strips - 50 Test Strips.
40301937308503Blood Glucose Test Strips - 50 Test Strips.

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