Philips FR2/FR2+ Infant/Child Defibrillation Pads
FR2 Infant/Child Reduced Energy Pads
6manufacturers in China registered for this device type
1catalogue number
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 | Philips Electronics North America Corporation |
|---|---|
| FDA product code | MLN |
| Device type | Electrode, Electrocardiograph, Multi-Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| Record published | 2014-09-24 |
| Record revised | 2024-05-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 0 to 43 °C; Storage environment temperature 32 to 110 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HeartStart Pediatric Pads FR2 | 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.