Henry Schein
Pad Defib Ped Philips
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | LDD |
| Device type | Dc-Defibrillator, Low-Energy, (Including Paddles) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5300 |
| 510(k) | K081442 |
| 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 |
|---|---|---|
| 1127165 | In distribution | |
| 1127164 | In distribution | |
| 1127168 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unipower | Unipower Corp. | 623 |
| Internal Handle | Zoll Medical Corporation | 89 |
| Vermed | Nissha Medical Technologies Limited | 47 |
| Cardio Clear | Cardio Medical Products, Inc. | 33 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | Fiab SPA | 20 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | Physio-Control, Inc. | 20 |
| R2 | ConMed Corporation | 17 |
| HeartStart | Philips Medical Systems Hsg | 9 |
| Anybattery | Anybattery, Inc | 6 |
| Tempus LS-Manual | Remote Diagnostic Technologies Ltd. | 6 |
| Vermed Defib Pads | Graphic Controls Acquisition Corporation | 5 |
| HeartStart | Philips Electronics North America Corporation | 4 |
Showing 12 of 29. All products under Dc-Defibrillator, Low-Energy, (Including Paddles)
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.