CONTOUR® NEXT ONE, CONTOUR® NEXT EZ, and CONTOUR® 9647

GUDID 40301939647518

Mixed product shipper case containing 3 CONTOUR® NEXT ONE Blood Glucose Monitoring System kits (Primary DI Number 00301939763012), 3 CONTOUR® NEXT EZ

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use
Primary Device ID40301939647518
NIH Device Record Keye7263558-ad0a-45b4-8bbe-814cc1616b33
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONTOUR® NEXT ONE, CONTOUR® NEXT EZ, and CONTOUR®
Version Model Number9647
Catalog Number9647
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 Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com
Phone18003488100
Emailsupport@contournext.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 48 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS140301939647518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-17

Devices Manufactured by ASCENSIA DIABETES CARE US INC.

40301937277359 - CONTOUR® NEXT2024-11-07 Blood Glucose Test strips. 35 test strips.
40301937278707 - CONTOUR® NEXT2024-11-07 Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total).
40301937097506 - CONTOUR®2024-11-06 Blood Glucose Test strips. 50 test strips.
40301937098503 - CONTOUR®2024-11-06 Blood Glucose Test strips. 50 test strips.
40301937099500 - CONTOUR®2024-11-06 Blood Glucose Test strips. 50 test strips.
00301937109010 - CONTOUR®2024-11-06 Control Solution - Normal, 1 x 2.5 mL
50301937110011 - CONTOUR®2024-11-06 Control Solution - Low, 1 x 2.5 mL
50301937111018 - CONTOUR®2024-11-06 Control Solution - High, 1 x 2.5 mL

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