Primary Device ID | 40301939765014 |
NIH Device Record Key | a73419a4-5926-4492-aef9-889b6678f03d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CONTOUR® NEXT ONE |
Version Model Number | 9765 |
Catalog Number | 9765 |
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 | 1-800-348-8100 |
support@contournext.com |
Storage Environment Temperature | Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00301939765016 [Primary] |
NDC/NHRIC | 0193-9765-01 [Secondary] |
GS1 | 40301939765014 [Package] Contains: 00301939765016 Package: shipper/case [4 Units] In Commercial Distribution |
LFR | Glucose Dehydrogenase, Glucose |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-12-16 |
40301939767018 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g |
40301939765014 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g |
40301939763010 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g |
40301937824010 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g |
00301937818011 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g |
40301939766011 | Kit contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit; MICROLET® NEXT Lancing De |
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40301939550016 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g |
40301937828018 | Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g |