Internal Handle
Steam Autoclavable Defibrillation Paddles, Front Panel Discharge (FOR R Series AND M Series ® With Software Versions 20.0 OR Later)
3manufacturers in China registered for this device type
89catalogue numbers in this listing
9510(k) clearances naming this product code
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 | Zoll Medical Corporation, United States |
|---|---|
| FDA product code | LDD |
| Device type | Dc-Defibrillator, Low-Energy, (Including Paddles) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5300 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K042302 |
| Record published | 2015-10-21 |
| Record revised | 2026-02-06 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure from 0 KiloPascal; Storage environment humidity 0 to 0 % RH; Handling environment temperature 0 to 0 °C; Storage environment temperature 0 to 0 °C |
| Distribution end date | 2026-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1011-0141-02 | In distribution | |
| 1003-1141-02 | In distribution | |
| 1011-0139-01 | In distribution | |
| 1003-1140-04 | In distribution | |
| 1011-0140-04 | In distribution | |
| 1011-0140-01-08 | In distribution | |
| 3330-000002-06 | In distribution | |
| 1003-1140-05 | In distribution | |
| 3330-000002-08 | In distribution | |
| 1011-0140-03 | In distribution | |
| 1011-0139-05 | In distribution | |
| 1003-0143-03 | In distribution | |
| 1003-1140-03 | In distribution | |
| 1003-0143-06 | In distribution | |
| 1011-0141-05 | In distribution | |
| 1003-0143-04 | In distribution | |
| 1003-1141-04 | In distribution | |
| 3330-000002-02 | In distribution | |
| 3330-000002-09 | In distribution | |
| 1003-1140-02 | In distribution | |
| 1011-0139-03 | In distribution | |
| 1003-1141-03 | In distribution | |
| 1011-0140-05 | In distribution | |
| 1003-1141-05 | In distribution | |
| 3330-000002-01 | In distribution | |
| 1011-0141-04 | In distribution | |
| 1011-0139-02 | In distribution | |
| 1011-0140-01 | In distribution | |
| 3330-000002-10 | In distribution | |
| 3330-000002-03 | In distribution | |
| 3330-000002-05 | In distribution | |
| 1001-0210 | In distribution | |
| 3330-000002-07 | In distribution | |
| 1011-0141-03 | In distribution | |
| 1003-1140-01 | In distribution | |
| 1003-1141-01 | In distribution | |
| 1011-0139-04 | In distribution | |
| 1011-0141-01 | In distribution | |
| 1011-0140-02 | In distribution | |
| 3330-000002-04 | In distribution | |
| 1011-0141-02-11 | Withdrawn | |
| 1011-0140-01-02 | Withdrawn | |
| 1011-0140-02-16 | Withdrawn | |
| 1011-0140-05-11 | Withdrawn | |
| 1011-0141-05-02 | Withdrawn | |
| 1011-0140-01-16 | Withdrawn | |
| 1011-0140-03-02 | Withdrawn | |
| 1011-0140-05-16 | Withdrawn | |
| 1011-0141-04-02 | Withdrawn | |
| 1011-0140-03-10 | Withdrawn | |
| 1011-0141-04-16 | Withdrawn | |
| 1011-0140-01-11 | Withdrawn | |
| 1011-0141-03-16 | Withdrawn | |
| 1011-0140-03-16 | Withdrawn | |
| 1011-0141-01-10 | Withdrawn | |
| 1011-0140-02-10 | Withdrawn | |
| 1011-0140-01-10 | Withdrawn | |
| 1011-0141-02-10 | Withdrawn | |
| 1011-0141-05-08 | Withdrawn | |
| 1011-0141-05-11 | Withdrawn | |
| 1011-0140-02-08 | Withdrawn | |
| 1011-0140-03-08 | Withdrawn | |
| 1011-0141-04-10 | Withdrawn | |
| 1011-0141-05-16 | Withdrawn | |
| 1011-0140-04-08 | Withdrawn | |
| 1011-0141-01-16 | Withdrawn | |
| 1011-0140-05-08 | Withdrawn | |
| 1011-0141-02-02 | Withdrawn | |
| 1011-0140-02-02 | Withdrawn | |
| 1011-0140-02-11 | Withdrawn | |
| 1011-0141-03-02 | Withdrawn | |
| 1011-0140-04-10 | Withdrawn | |
| 1011-0141-01-08 | Withdrawn | |
| 1011-0141-01-02 | Withdrawn | |
| 1011-0140-04-11 | Withdrawn | |
| 1011-0141-01-11 | Withdrawn | |
| 1011-0140-03-11 | Withdrawn | |
| 1011-0141-04-08 | Withdrawn | |
| 1011-0141-02-16 | Withdrawn | |
| 1011-0140-04-16 | Withdrawn | |
| 1011-0141-03-10 | Withdrawn | |
| 1011-0141-03-11 | Withdrawn | |
| 1011-0140-04-02 | Withdrawn | |
| 1011-0141-03-08 | Withdrawn | |
| 1011-0141-02-08 | Withdrawn | |
| 1011-0140-05-02 | Withdrawn | |
| 1011-0140-05-10 | Withdrawn | |
| 1011-0141-05-10 | Withdrawn | |
| 1011-0141-04-11 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unipower | Unipower Corp. | 623 |
| 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 |
| Heartsync by Vermed | Graphic Controls Acquisition Corporation | 4 |
Showing 12 of 29. All products under Dc-Defibrillator, Low-Energy, (Including Paddles)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140502 | 2014-11-06 |
| K081574 | 2008-09-18 |
| K042302 | 2004-10-26 |
| K032691 | 2003-11-13 |
| K963781 | 1997-05-20 |
| K931787 | 1993-10-15 |
| K931804 | 1993-10-08 |
| K931805 | 1993-10-08 |
| K931803 | 1993-10-08 |
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.