Primary Device ID | 40301939768510 |
NIH Device Record Key | 50cd459d-823b-4b3a-a52e-a37812d0dfd2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CONTOUR® NEXT ONE, CONTOUR® NEXT and MICROLET® |
Version Model Number | 9768 |
Catalog Number | 9768 |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
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 | 1 (800) 348-8100 |
support@contournext.com | |
Phone | 1 (800) 348-8100 |
support@contournext.com |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 40301939768510 [Primary] |
FMK | Lancet, Blood |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-09-20 |
Device Publish Date | 2018-05-25 |
40301939768510 | Mixed product shipper case containing 1 CONTOUR® NEXT ONE Blood Glucose Monitoring System kit ( |
40301939780512 | Mixed product shipper case containing 1 CONTOUR® NEXT ONE Blood Glucose Monitoring System kit ( |