Henry Schein
Pad Defib Philips T100AC
6manufacturers in China registered for this device type
3catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | MLN |
| Device type | Electrode, Electrocardiograph, Multi-Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2360 |
| 510(k) | K080421 |
| Record published | 2016-09-24 |
| Record revised | 2023-02-20 (version 4) |
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 -20 to 40 °C |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1127166 | In distribution | |
| 1127167 | In distribution | |
| 1127163 | 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 |
| 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.