Duns Number:231959888
Device Description: The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a dispos 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 72 hours before a replacement is required.
Catalog Number
-
Brand Name
Zensor electrode
Version/Model Number
PN1088
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MLN
Product Code Name
Electrode, Electrocardiograph, Multi-Function
Public Device Record Key
e10b998a-3ed5-4953-aac8-10b98751c6eb
Public Version Date
June 14, 2018
Public Version Number
1
DI Record Publish Date
May 14, 2018
Package DI Number
15060484630010
Quantity per Package
4
Contains DI Package
05060484630013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |