| Primary Device ID | 20385540109722 |
| NIH Device Record Key | 5131f7f4-08a0-4016-9807-8127740f73fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CareSens S Fit |
| Version Model Number | 8000-10972 |
| Company DUNS | 156756129 |
| Company Name | AGAMATRIX, 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 | true |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385540109728 [Primary] |
| GS1 | 20385540109722 [Package] Contains: 00385540109728 Package: Shipper [12 Units] In Commercial Distribution |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-12 |
| Device Publish Date | 2025-08-04 |
| 20385540109722 - CareSens S Fit | 2025-08-12CareSens S Fit System Kit |
| 20385540109722 - CareSens S Fit | 2025-08-12 CareSens S Fit System Kit |
| 20385540109753 - CareSens S | 2025-08-12 CareSens S Control Solution |
| 00385540109742 - CareSens S | 2025-08-12 CareSens S Test Strip 50ct Vial |
| 00385540132504 - AgaMatrix Lancing Device | 2023-09-26 |
| 00385541062206 - AgaMatrix Lancing Device | 2023-09-26 |
| 10385541000700 - AgaMatrix | 2021-12-30 Blood Glucse Meter, Agamatrix, Presto PRO, mg/dL |
| 10385542661016 - AgaMatrix | 2021-12-30 Blood Glucose Meter, AgaMatrix, Presto, mg/dL |
| 20385541000806 - AgaMatrix | 2018-12-03 System Kit, Blood Glucse Meter, Agamatrix, Presto PRO, mg/dL |