Curaplex
Curaplex Select Defib Pads, Philips Adult Combo, Leads Out Direct Connect 10pr/cs
6manufacturers in China registered for this device type
6catalogue numbers in this listing
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 | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | MLN |
| Device type | Electrode, Electrocardiograph, Multi-Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| Establishment | Manufacturer |
| 510(k) | K080421 |
| Record published | 2016-12-14 |
| Record revised | 2023-02-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16250 | In distribution | |
| 16381 | In distribution | |
| 16242 | In distribution | |
| 16244 | In distribution | |
| 16240 | In distribution | |
| 16384 | 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 |
| 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 |
| Heart Sync Adult/Child Radio Transparent Multi Function Electrodes | Heart Sync, LLC | 2 |
Showing 12 of 24. All products under Electrode, Electrocardiograph, Multi-Function
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | 510(k) number | 2010-12-17 | Not classified | Packaging | The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, ” Do not open package until immediately prior to using electrodes. and Electrodes may dry | 300 | 2011-07-13 |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | 510(k) number | 2010-12-17 | Not classified | Packaging | The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, ” Do not open package until immediately prior to using electrodes. and Electrodes may dry | 300 | 2011-07-13 |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | 510(k) number | 2008-12-05 | Not classified | Equipment maintenance | The “leads out” connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. | 2100 (210 cases of 10 each) | 2011-04-13 |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | 510(k) number | 2008-12-05 | Not classified | Equipment maintenance | The “leads out” connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. | 50 (5 cases of 10 each) | 2011-04-13 |
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.