GLUCOFACTS® DELUXE 3515
GUDID 00301933515013
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
Self-care monitoring/reporting software| Primary Device ID | 00301933515013 |
| NIH Device Record Key | bdd4e750-bd12-475b-b7ab-22b755ce086e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GLUCOFACTS® DELUXE |
| Version Model Number | 3515 |
| Catalog Number | 3515 |
| 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 | true |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00301933515013 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091820
FDA Product Code
| JQP | Calculator/Data Processing Module, For Clinical Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-16 |
Devices Manufactured by ASCENSIA DIABETES CARE US INC.
| 40301939732023 - CONTOUR® NEXT GEN | 2025-01-28 "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, 10 CONTOU |
| 40301937035027 - CONTOUR® Plus Blue | 2025-01-14 "For self - testing, monitoring, and management of blood glucose. Kit contains: -Contour Plus Blue blood glucose meter (Product |
| 40301939628029 - CONTOUR® NEXT EZ | 2025-01-14 Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. This kit contains the fo |
| 40301937277359 - CONTOUR® NEXT | 2024-11-07 Blood Glucose Test strips. 35 test strips. |
| 40301937278707 - CONTOUR® NEXT | 2024-11-07 Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total). |
| 40301937097506 - CONTOUR® | 2024-11-06 Blood Glucose Test strips. 50 test strips. |
| 40301937098503 - CONTOUR® | 2024-11-06 Blood Glucose Test strips. 50 test strips. |
| 40301937099500 - CONTOUR® | 2024-11-06 Blood Glucose Test strips. 50 test strips. |
Trademark Results [GLUCOFACTS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GLUCOFACTS 74180244 1694159 Live/Registered |
ASCENSIA DIABETES CARE HOLDINGS AG 1991-06-27 |
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