| Primary Device ID | 16971404130918 |
| NIH Device Record Key | ea0e18bb-9188-4cf6-9786-7a8f93c452e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blood Ketone Monitoring System |
| Version Model Number | PM900B |
| 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 | 06971404130911 [Primary] |
| GS1 | 16971404130918 [Package] Contains: 06971404130911 Package: Pack [1 Units] In Commercial Distribution |
| GS1 | 26971404130915 [Package] Package: Carton [24 Units] In Commercial Distribution |
| GS1 | 26971404131332 [Package] Contains: 06971404130911 Package: pack [1 Units] In Commercial Distribution |
| GS1 | 36971404131339 [Package] Contains: 26971404131332 Package: Carton [24 Units] In Commercial Distribution |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) |
| 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 | 2021-12-27Blood ketone Monitoring Meter with Blood Ketone Test Strips are intended for use for the quantitative measurement of B -hydroxybutyrate (B -ketone) in fresh capillary whole blood or venous whole blood. |
| 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 | 2021-12-27 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 |