R2
R2 Multifunction Electrode Accessories, Hewlett Packard Codemaster TO R2 Multifunction Adapter
3manufacturers in China registered for this device type
17catalogue numbers in this listing
3recalls on this 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 | ConMed 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, Exporter |
| Record published | 2015-10-24 |
| Record revised | 2025-08-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment humidity up to 85 % RH; Storage environment temperature 41 to 95 °F; Storage environment humidity 10 to 90 % RH; Handling environment temperature -4 to 131 °F; Storage environment temperature 5 to 35 °C; Handling environment temperature -20 to 55 °C |
| Distribution end date | 2020-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-184572X | In distribution | |
| 3200-1715 | Withdrawn | |
| 32-170471 | Withdrawn | |
| 32-184554 | Withdrawn | |
| 32-184571X | Withdrawn | |
| 3114-1741 | Withdrawn | |
| 32-170555 | Withdrawn | |
| 3111-1720 | Less than or equal to 100J/25kg | Withdrawn |
| 32-184554X | Withdrawn | |
| 32-170470 | Withdrawn | |
| 3111-1721 | Withdrawn | |
| 3115-1751 | Withdrawn | |
| 32-184572 | Withdrawn | |
| 3114-1740 | Withdrawn | |
| 3200-1711 | Withdrawn | |
| 32-184571 | Withdrawn | |
| 3115-1750 | Withdrawn |
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 |
| 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)
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-11-06 | Class I | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death | 174,610 (168,090 US and 6,520 OUS) in total. | 2017-10-30 |
| 2014-11-06 | Class I | Device Design | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death | 174,610 (168,090 US and 6,520 OUS) in total. | 2017-10-30 |
| 2011-03-09 | Not classified | Packaging process control | The product lot was assembled with an R2 Connector, rather than a Zoll Connector. | 190 sets (2 pads per set in individual pouch) | 2012-01-12 |
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.