Aingeal 3-Patch Electrode
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…
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.
Who Else Makes It
Concentrated in Shandong (3), Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Intelesens Limited, United Kingdom |
|---|---|
| FDA product code | MLN |
| Device type | Electrode, Electrocardiograph, Multi-Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| Premarket notification | Exempt |
| Record published | 2017-02-01 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 25, foil pouch of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PN1120 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Regard™ | Resource Optimization & Innovation, L.L.C. | 25 |
| Medline | Medline Industries, Inc. | 15 |
| Heartsync by Vermed | Graphic Controls Acquisition Corporation | 9 |
| Curaplex | Bound Tree Medical, LLC | 6 |
| Adult/Child, radiotransparent, defib electrodes with increased adhesive surface | Heart Sync, LLC | 6 |
| Henry Schein | Henry Schein, Inc. | 3 |
| MediChoice | Owens & Minor Distribution, Inc. | 3 |
| Adult/Child, radiotransparent, leads out, defib electrodes w/ Phillips connector | Heart Sync, LLC | 3 |
| Adult/Child, radiolucent, leads out, defib electrodes w/ Zoll connector | Heart Sync, LLC | 3 |
| BodyGuardian | Preventice Technologies, Inc. | 3 |
| Zensor electrode | Intelesens Limited | 2 |
| Adult/Child, radiotransparent, defib electrodes w/ Zoll connector | Heart Sync, LLC | 2 |
Showing 12 of 24. All products under Electrode, Electrocardiograph, Multi-Function
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.