| Primary Device ID | M582NEMK1270 |
| NIH Device Record Key | 943319d6-2966-4bc5-a8c0-b443cc161987 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Holter Analysis Software Apnea |
| Version Model Number | Holter Analysis Software Apnea |
| Catalog Number | M582NEMK127 |
| Company DUNS | 837441815 |
| Company Name | Northeast Monitoring, 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M582NEMK1270 [Primary] |
| MNR | Ventilatory Effort Recorder |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-04 |
| Device Publish Date | 2021-10-27 |
| M581NEMK1290 - DR200 | 2021-11-04 DR200 holter recorder w/ 3L patient cable |
| M581NEMK1380 - DR181 | 2021-11-04 DR181 holter recorder w/ 5L patient cable |
| M581NEMK1390 - DR181 | 2021-11-04 DR181 holter recorder w/ 7L patient cable |
| M581NEMK1400 - DR181 | 2021-11-04 DR181 holter recorder w/ 10L patient cable |
| M581NEMK1540 - DR300 | 2021-11-04 DR300 holter recorder w/ 5L patient cable |
| M581NEMK1550 - DR300 | 2021-11-04 |
| M581NEMK1560 - Gateway | 2021-11-04 Gateway NEMK156 |
| M581NEMK1570 - DR400 | 2021-11-04 DR400 holter recorder with NEMEL002/003 patches |