| Primary Device ID | M581NEMK1570 |
| NIH Device Record Key | a3d1c2f2-ec07-4bea-8805-958f8f65792d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DR400 |
| Version Model Number | DR400 |
| Catalog Number | NEMK157 |
| 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 | true |
| 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 |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Length | 6.7 Centimeter |
| Width | 3.8 Centimeter |
| Depth | 1.2 Centimeter |
| Weight | 35 Gram |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Special Storage Condition, Specify | Between 0 and 0 *Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M581NEMK1570 [Primary] |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) |
| 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 | 2021-11-04DR400 holter recorder with NEMEL002/003 patches |
| M581NEMK1570 - DR400 | 2021-11-04 DR400 holter recorder with NEMEL002/003 patches |