| Primary Device ID | 06944413802018 |
| NIH Device Record Key | d35d807c-5eb0-4b69-88b3-e3c214e2c1bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hematocrit Control |
| Version Model Number | High |
| Company DUNS | 529173163 |
| Company Name | Edan Instruments, Inc. |
| Device Count | 5 |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06944413802018 [Primary] |
| GS1 | 06944413807891 [Unit of Use] |
| GLK | Control, Hematocrit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-01 |
| 06944413820463 - Holter ECG and ABP System | 2023-12-08 |
| 06944413820470 - Holter ECG and ABP System | 2023-12-08 |
| 06944413820487 - Holter ECG and ABP System | 2023-12-08 |
| 06944413820494 - Holter ECG and ABP System | 2023-12-08 |
| 06944413820500 - Holter ECG and ABP System | 2023-12-08 |
| 06944413820562 - Electrocardiograph | 2023-12-08 |
| 06944413820616 - Electrocardiograph | 2023-12-08 |
| 06944413812680 - Ambulatory Blood Pressure Monitor | 2023-06-29 |