Duns Number:231959888
Device Description: The Aingeal 3-Patch Electrode Array is an electrocardiograph (ECG), respiration and temper The Aingeal 3-Patch Electrode Array is an electrocardiograph (ECG), respiration and temperature electrode. It is a disposable, pre-gelled, self-adhesive, single lead electrode array, which is designed to be used in contact with the patient’s skin. The device is used in conjunction with the Aingeal Device in order to monitor vital signs for ECG, respiration, motion and temperature for ambulatory and non-ambulatory patients in a hospital 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
Aingeal 3-patch electrode
Version/Model Number
PN1120
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, Electrodcardiograph, Multi-Function
Public Device Record Key
15ae9471-73f7-4ad1-a443-5951eb63abd1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 01, 2017
Package DI Number
25060484630031
Quantity per Package
25
Contains DI Package
15060484630034
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |