Primary Device ID | 40301937383012 |
NIH Device Record Key | 2695e7a5-db05-4d95-b8b7-b4f2b07abcd4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CONTOUR® NEXT GEN |
Version Model Number | 7383 |
Catalog Number | 90004850 |
Company DUNS | 080028910 |
Company Name | ASCENSIA DIABETES CARE US INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 800-348-8100 |
support@contournext.com | |
Phone | 800-348-8100 |
support@contournext.com | |
Phone | 800-348-8100 |
support@contournext.com | |
Phone | 800-348-8100 |
support@contournext.com | |
Phone | 800-348-8100 |
support@contournext.com | |
Phone | 800-348-8100 |
support@contournext.com | |
Phone | 800-348-8100 |
support@contournext.com | |
Phone | 800-348-8100 |
support@contournext.com |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00301937383014 [Primary] |
NDC/NHRIC | 0193-7383-01 [Secondary] |
GS1 | 40301937383012 [Package] Contains: 00301937383014 Package: shipper/case [4 Units] In Commercial Distribution |
NBW | System, Test, Blood Glucose, Over The Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-08 |
Device Publish Date | 2022-06-30 |
40301939658019 | "Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood |
40301937383012 | "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GE |
00301937917011 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g |
40301939732016 | "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GE |
40301937922013 | "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GE |