| Primary Device ID | 00850028319048 |
| NIH Device Record Key | 1afcccb4-eaa8-4d02-980a-c02602a9ba69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mortara H3+ Monitoring System Kit |
| Version Model Number | 2001KIT-MORTARA |
| Company DUNS | 176104664 |
| Company Name | Preventice Services, 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850028319048 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-29 |
| Device Publish Date | 2022-03-21 |
| 00850028319000 - BodyGuardian One Remote Monitoring System Kit | 2022-03-29 |
| 00850028319017 - BodyGuardian Heart Remote Monitoring System Kit | 2022-03-29 |
| 00850028319024 - BodyGuardian Mini Remote Monitoring System Kit | 2022-03-29 |
| 00850028319031 - BodyGuardian Mini Plus Remote Monitoring System Kit | 2022-03-29 |
| 00850028319048 - Mortara H3+ Monitoring System Kit | 2022-03-29 |
| 00850028319048 - Mortara H3+ Monitoring System Kit | 2022-03-29 |
| 00850028319055 - PER900 Monitoring System Kit | 2022-03-29 |