FDA UDI
In Commercial Distribution
🇺🇸 United States
Zensor+ software
DI: 05060484630051
·
Model: PN0811
·
INTELESENS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zensor+ software
- Primary DI
- 05060484630051
- Version / Model
- PN0811
- Company Name
- INTELESENS LIMITED
- Labeler DUNS
- 231959888
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-15
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 0a4d1f5e-1563-4583-b41f-1f913d79503f
Device Description
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together. The zensor+ software allows review of all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31733 | Electrocardiography telemetric monitoring system | An assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060484630051 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151027 | 000 |