Primary Device ID | 40301937283350 |
NIH Device Record Key | b1653fc7-fb56-4f31-b79e-5f24d1376209 |
Commercial Distribution Discontinuation | 2018-10-24 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | CONTOUR® NEXT |
Version Model Number | 7283 |
Catalog Number | 7283 |
Company DUNS | 080028910 |
Company Name | ASCENSIA DIABETES CARE US INC. |
Device Count | 35 |
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 | true |
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 | true |
OTC Over-The-Counter | true |
Phone | 18003488100 |
support@contournext.com |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00301937283017 [Unit of Use] |
GS1 | 00301937283352 [Primary] |
NDC/NHRIC | 0193-7283-35 [Secondary] |
GS1 | 40301937283350 [Package] Contains: 00301937283352 Package: shipper/case [12 Units] Discontinued: 2018-10-24 Not in Commercial Distribution |
OZO | Artificial Pancreas Device System, Threshold Suspend |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-06-07 |
Device Publish Date | 2016-09-16 |
40301939697018 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabete |
40301937379015 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood gl |
40301937377011 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood gl |
40301937283350 | Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 1030193731025 |
10301937313100 | Blood Glucose Test Strips - 10 Test Strips. |
40301939737219 | Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 tes |
40301939736502 | Blood Glucose Test Strips - 50 Test Strips. |
40301939735253 | Blood Glucose Test Strips - 25 Test Strips. |
40301937357501 | Blood Glucose Test Strips - 50 Test Strips. |
40301937308503 | Blood Glucose Test Strips - 50 Test Strips. |