| Primary Device ID | 90815187020399 |
| NIH Device Record Key | d6f4ccf0-8750-416a-8754-32e1c2d15243 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Matrix Holter System |
| Version Model Number | M12A |
| Catalog Number | 005-400-0068 |
| Company DUNS | 147035427 |
| Company Name | GLOBAL INSTRUMENTATION, LLC |
| 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 | false |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 90815187020399 [Primary] |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2018-03-22 |
| 90815187020399 | M12A Enterprise System Software |
| 90815187020382 | M12A Office System Software |
| 90815187020719 | M12R L Recorder, 10-Lead Cable, AHA, System Kit 90815187020184; M12R, 10 Lead patient Cable (DIN |
| 90815187020702 | M12R Recorder, 7-Lead Cable AHA, System Kit 90815187020153; M12R, 7 Lead patient Cable (AHA) 908 |
| 90815187020696 | M12R Recorder, 10-Lead Cable AHA, System Kit 90815187020191; M12R, 10 Lead Patient Cable 9081518 |