| Primary Device ID | 16971404130925 |
| NIH Device Record Key | 77dd8ece-d8cd-42f2-bb49-9ceff870f0f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blood Uric Acid Monitoring System |
| Version Model Number | PM900C |
| Company DUNS | 540481217 |
| Company Name | e-Linkcare Meditech Co., Ltd |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| 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 | 06971404130928 [Primary] |
| GS1 | 16971404130925 [Package] Contains: 06971404130928 Package: Pack [1 Units] In Commercial Distribution |
| GS1 | 26971404130922 [Package] Package: Carton [24 Units] In Commercial Distribution |
| GS1 | 26971404131349 [Package] Contains: 06971404130928 Package: Pack [1 Units] In Commercial Distribution |
| GS1 | 36971404131346 [Package] Contains: 26971404131349 Package: Carton [24 Units] In Commercial Distribution |
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-27 |
| Device Publish Date | 2021-12-17 |
| 06971404131581 - Blood Ketone Control solution(level 1) | 2022-05-25 It is used to confirm that your Blood Ketone Test Strips and Multi-Monitoring Meter are working together properly and that you a |
| 06971404131598 - Blood Ketone Control solution(level 2) | 2022-05-25 It is used to confirm that your Blood Ketone Test Strips and Multi-Monitoring Meter are working together properly and that you a |
| 06971404131604 - Blood Ketone Control solution(level 3) | 2022-05-25 It is used to confirm that your Blood Ketone Test Strips and Multi-Monitoring Meter are working together properly and that you a |
| 06971404131611 - Uric Acid Control solution(level 1) | 2022-05-25 It is used to confirm that your Blood Uric Acid Test Strips and Multi-Monitoring Meter are working together properly and that yo |
| 06971404131628 - Uric Acid Control solution(level 2) | 2022-05-25 It is used to confirm that your Blood Uric Acid Test Strips and Multi-Monitoring Meter are working together properly and that yo |
| 16971404130918 - Blood Ketone Monitoring System | 2021-12-27 Blood ketone Monitoring Meter with Blood Ketone Test Strips are intended for use for the quantitative measurement of B -hydroxyb |
| 16971404130925 - Blood Uric Acid Monitoring System | 2021-12-27Blood uric acid Monitoring Meter with Blood Uric Acid Test Strips are intended for use for the quantitative measurement of uric acid in fresh capillary whole blood or venous whole blood |
| 16971404130925 - Blood Uric Acid Monitoring System | 2021-12-27 Blood uric acid Monitoring Meter with Blood Uric Acid Test Strips are intended for use for the quantitative measurement of uric |
| 26971404130946 - Blood Uric Acid Test Strips | 2021-12-27 Blood uric acid Monitoring Meter with Blood Uric Acid Test Strips are intended for use for the quantitative measurement of uric |