FDA UDI
In Commercial Distribution
🇺🇸 United States
Zensor electrode
DI: 05060484630099
·
Model: PN1360
·
INTELESENS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zensor electrode
- Primary DI
- 05060484630099
- Version / Model
- PN1360
- Company Name
- INTELESENS LIMITED
- Labeler DUNS
- 231959888
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-21
- Public Version
- 1
- Public Version Date
- 2019-01-21
- Public Version Status
- New
- Public Device Record Key
- 0d339835-90f0-451d-b1f3-c0bbda800a59
Device Description
The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three lead electrode array, which is in contact with the patient's skin. The device is used in conjunction with the zensor device in order to monitor vital signs for ECG, respiration and motion for ambulatory and non-ambulatory patients in a home environment. This is a single use device and is intended to be used on an adult patient for a period of up to 6 days before a replacement is required.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MLN | Electrode, Electrocardiograph, Multi-Function | Cardiovascular | 870.2360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35035 | Electrocardiographic electrode, single-use | A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060484630099 | GS1 |