ViSi 93-10019
GUDID 00850733007070
ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measure ECG, heart rate, respiration rate and temperature of adult patients (18 years or older).
SOTERA WIRELESS, INC.
Single-patient intensive/general healthcare physiologic monitoring system| Primary Device ID | 00850733007070 |
| NIH Device Record Key | c4a63ec2-ec1c-421a-b4bb-6c9e3f872365 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ViSi |
| Version Model Number | Chest Sensor, 3 Lead, IEC, WH |
| Catalog Number | 93-10019 |
| Company DUNS | 167142491 |
| Company Name | SOTERA WIRELESS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850733007070 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152341
FDA Product Code
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2016-09-19 |
On-Brand Devices [ViSi]
| 00850733007094 | The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers |
| 00850733007087 | The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers |
| 00850733007070 | ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measu |
| 00850733007063 | ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measu |
| 00850733007056 | ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measu |
| 00850733007049 | ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measu |
| 10850733007039 | ViSi NIBP Adapter is an accessory intended to connect ViSi Cuff Module with a non-ViSi NIBP Cuff |
| 00850733007025 | The ViSi thumb sensor is an accessory intended to use together with the ViSi Mobile Monitor to m |
| 00850733007018 | ViSi Cuff Module is an accessory intended for use together with the ViSi Mobile Monitor to measu |
| 00850733007001 | The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers |
| 10850733007305 | Chest Sensor Securements, 3M |
| 00850733007186 | Thumb Tape (Qty 100) |
| 00850733007414 | ViSi Emergency Medical Surveillance (EMS) Kit |
| 00850733007407 | Chest Sensor Securements (Qty 100) |
| 00850733007384 | ViSi Mobile Charger, 8-Bay |
| 00850733007377 | ViSi Mobile Charger, 2-Bay |
| 00850733007353 | Disposable Wrist Cradle, Large (Qty 20) |
| 00850733007339 | Disposable Wrist Cradle, Medium (Qty 20) |
| 00850733007315 | Disposable Wrist Cradle, Small (Qty 20) |
| 00850733007278 | Disposable Adult Cuff, Large+ (Qty 20) |
| 00850733007254 | Disposable Adult Cuff, Large (Qty 20) |
| 00850733007230 | Disposable Adult Cuff, Medium+ (Qty 20) |
| 00850733007216 | Disposable Adult Cuff, Medium (Qty 20) |
| 00850733007193 | Disposable Adult Cuff, Small (Qty 20) |
| 00850733007162 | Thumb Wrap (Qty 100) |
| 00850733007155 | ViSi Mobile Cuff Module, Refurbished |
| 00850733007148 | Reusable cNIBP & SpO2 Thumb Sensor |
Trademark Results [ViSi]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VISI 97799419 not registered Live/Pending |
Taylor, David 2023-02-17 |
 VISI 97609391 not registered Live/Pending |
CLOUDBERRY NUTRITIONALS LLC 2022-09-27 |
 VISI 90754181 not registered Live/Pending |
SmartHome Ventures, LLC 2021-06-04 |
 VISI 88890686 not registered Live/Pending |
Taylor, David 2020-04-28 |
 VISI 87553934 not registered Dead/Abandoned |
ViSi Inc. 2017-08-02 |
 VISI 87073583 5357608 Live/Registered |
Display Technologies, LLC 2016-06-16 |
 VISI 86067482 5612080 Live/Registered |
Display Technologies, LLC 2013-09-17 |
 VISI 85658312 not registered Dead/Abandoned |
Sterling International Inc. 2012-06-21 |
 VISI 85565843 4262616 Live/Registered |
CLOUDBERRY NUTRITIONALS LLC 2012-03-09 |
 VISI 78776196 3414569 Dead/Cancelled |
Vector Internet Services, Inc. 2005-12-19 |
 VISI 78318174 not registered Dead/Abandoned |
BRATTESANI, Steven J. 2003-10-24 |
 VISI 78075040 not registered Dead/Abandoned |
Visual Information Systems International, Inc. 2001-07-21 |
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