Contour Plus 90006349
GUDID 40301937594012
Control Solution - Level 2. 1 x 2.5 mL.
ASCENSIA DIABETES CARE US INC.
Glucose monitoring system IVD, home-use| Primary Device ID | 40301937594012 |
| NIH Device Record Key | b6154b8a-02b8-4920-89b1-cd0bc43b3887 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Contour Plus |
| Version Model Number | 7594 |
| Catalog Number | 90006349 |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00301937594014 [Primary] |
| GS1 | 40301937594012 [Package] Contains: 00301937594014 Package: shipper/case [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231679
FDA Product Code
| NBW | System, Test, Blood Glucose, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-09 |
| Device Publish Date | 2024-08-01 |
On-Brand Devices [Contour Plus]
| 40301937594012 | Control Solution - Level 2. 1 x 2.5 mL. |
| 40301937593015 | Control Solution - Level 1. 1 x 2.5 mL. |
| 40301937584501 | Blood Glucose Test Strips. 50 test strips. |
Trademark Results [Contour Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CONTOUR PLUS 90000797 not registered Live/Pending |
KuduPointUSA LLC 2020-06-14 |
 CONTOUR PLUS 86167781 not registered Dead/Abandoned |
Gibbons Health Products Inc. 2014-01-16 |
 CONTOUR PLUS 74706855 not registered Dead/Abandoned |
KRACO ENTERPRISES, INC. 1995-07-27 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.