Primary Device ID | 40301936586124 |
NIH Device Record Key | 55dfab27-fce9-4952-97fc-e7516661e22c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MICROLET® |
Version Model Number | 6586 / 6586W |
Catalog Number | 81264857, 81264954 (US) |
Company DUNS | 080028910 |
Company Name | ASCENSIA DIABETES CARE US INC. |
Device Count | 100 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 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 | |
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 | |
Phone | 800-348-8100 |
support@contournext.com |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00301936586010 [Unit of Use] |
GS1 | 00301936586218 [Primary] |
NDC/NHRIC | 0193-6586-21 [Secondary] |
GS1 | 40301936586124 [Package] Contains: 00301936586218 Package: shipper/case [12 Units] In Commercial Distribution |
GS1 | 40301936586216 [Package] Contains: 00301936586218 Package: shipper/case [24 Units] In Commercial Distribution |
FMK | Lancet, Blood |
QRL | Multiple Use Blood Lancet For Single Patient Use Only |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-06-14 |
Device Publish Date | 2019-06-06 |
40301937922013 - CONTOUR® NEXT GEN | 2023-07-31 "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, Lancing D |
40301939732016 - CONTOUR® NEXT GEN | 2023-07-31 "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, 10 CONTOU |
40301939660517 - CONTOUR® NEXT EZ, CONTOUR® NEXT GEN and CONTOUR® NEXT | 2022-12-01 Mixed product shipper case containing 3 CONTOUR® NEXT EZ Blood Glucose Monitoring System kits (Primary DI Number 00301939628014 |
40301939725254 - CONTOUR® | 2022-10-07 Blood Glucose Test strips. 25 test strips. |
00301937917011 - CONTOUR® NEXT GEN | 2022-07-11 Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® |
40301937383012 - CONTOUR® NEXT GEN | 2022-07-08 "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, 20 CONTOU |
40301939658019 - CONTOUR® NEXT GEN | 2022-07-08 "Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® |
00301933536018 - CONTOUR® DIABETES APP | 2022-02-28 Diabetes Management Software |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MICROLET 88151546 not registered Live/Pending |
Ascensia Diabetes Care Holdings AG 2018-10-11 |
MICROLET 75069425 2100253 Dead/Cancelled |
BAYER CORPORATION 1996-03-08 |