CONTOUR® DIABETES APP 85498754
GUDID 00301933537015
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
Self-care monitoring/reporting software| Primary Device ID | 00301933537015 |
| NIH Device Record Key | d9859855-d47a-4d66-ac38-373c7c5a2b37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONTOUR® DIABETES APP |
| Version Model Number | 3537 |
| Catalog Number | 85498754 |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00301933537015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193407
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 | 2022-02-28 |
| Device Publish Date | 2022-02-18 |
On-Brand Devices [CONTOUR® DIABETES APP]
| 00301933537015 | Diabetes Management Software |
| 00301933536018 | Diabetes Management Software |
Trademark Results [CONTOUR]
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