FDA UDI
In Commercial Distribution
🇺🇸 United States
ViSi
DI: 00850733007414
·
Model: ViSi Emergency Medical Surveillance (EMS) Kit
·
Sotera Wireless, Inc.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ViSi
- Primary DI
- 00850733007414
- Version / Model
- ViSi Emergency Medical Surveillance (EMS) Kit
- Catalog Number
- 97-10259
- Company Name
- Sotera Wireless, Inc.
- Labeler DUNS
- 167142491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-24
- Public Version
- 3
- Public Version Date
- 2022-05-16
- Public Version Status
- Update
- Public Device Record Key
- ca7ddc65-388c-4dd1-8270-1b9bd25a1b4d
Device Description
ViSi Emergency Medical Surveillance (EMS) Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
| MWI | Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | 870.1025 | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33586 | General-purpose multi-parameter bedside monitor | An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850733007414 | GS1 |
Customer Contacts
- Phone
- 1-858-427-4620
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152341 | 000 |