| Primary Device ID | 00850733007124 |
| NIH Device Record Key | bf5f81a4-b2a7-4734-bd06-da8a91c77aaa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ViSi Mobile System Package |
| Version Model Number | 3-lead IEC |
| Catalog Number | 92-10096 |
| Company DUNS | 167142491 |
| Company Name | SOTERA WIRELESS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
|---|---|
| GS1 | 00850733007124 [Primary] |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2018-05-21 |
| 00850733007131 | The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers |
| 00850733007124 | The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers |
| 00850733007117 | The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers |
| 00850733007100 | The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers |