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Sign in to claim this brandRPI
US
Last updated May 24, 2026
What RPI makes
The company manufactures reusable and single-use electrocardiographic lead sets, including patient cables and leadwires in various configurations and lengths, as well as reusable skin temperature probes. It also produces infant warmers with heating elements and professional-grade blue-light phototherapy lamps designed for medical use, including models with specific wattage and voltage specifications.
These devices are classified as Class II under regulatory standards and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable medical device regulations in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does RPI manufacture?
RPI manufactures a range of reusable and single-use medical devices primarily focused on cardiac monitoring and patient care. These include electrocardiographic (ECG) lead sets, such as reusable and single-use leadwires and patient cables in various configurations (e.g., 3-lead or 5-lead), as well as reusable skin temperature probes. Additionally, the company produces infant warmers with heating elements and professional-grade blue-light phototherapy lamps, which are designed for medical use with specific power specifications (e.g., 50W, 560W).
Where is RPI based, and does its location affect the devices it manufactures?
RPI is based in the United States. Since the company operates within this jurisdiction, its devices must comply with U.S. medical device regulations, including classification and listing requirements. The location influences the regulatory framework governing its products, such as the need to list devices in the FDA’s Unique Device Identifier (UDI) database, but it does not inherently limit the types of devices produced—only ensures they meet applicable U.S. standards.
How are RPI’s devices classified under regulatory standards?
RPI’s devices are classified as Class II under regulatory standards. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. For example, ECG lead sets and phototherapy lamps fall into this category because they interact with patients but do not carry the highest risk (e.g., life-supporting or implantable devices). The classification determines the regulatory pathway and oversight required for each device.
Are RPI’s devices listed in any regulatory registries, and why does this matter?
Yes, RPI’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry assigns a unique code to each device model, enabling better tracking, traceability, and transparency in the medical device supply chain. Listing in the UDI database is mandatory for Class II devices in the U.S. to facilitate recalls, post-market surveillance, and compliance monitoring. It also helps healthcare providers and regulators quickly identify and verify the specific device being used.
What distinguishes RPI’s reusable and single-use electrocardiographic lead sets?
RPI produces both reusable and single-use electrocardiographic lead sets, differing primarily in their intended lifespan and sterilization requirements. Reusable lead sets (e.g., skin temperature probes or certain leadwires) are designed for multiple uses with proper cleaning and sterilization between patients, while single-use sets (e.g., specific leadwire configurations) are intended for one-time use only to minimize infection risks. The choice between reusable and single-use depends on clinical protocols, cost considerations, and infection control policies in healthcare settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- rpiparts.com
- —
- —
- [email protected]
- Phone
- 818-882-8611
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 066232067
Catalogue (156)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 3 Leadwire Set - 40" Du/Sn | LKM017 | FDA UDI | Class II | Active |
| Patient Cable - 3 Ld Fx Sn | KCB002 | FDA UDI | Class II | Active |
| Lamp | LMP016 | FDA UDI | Class II | Active |
| Heating Element 600w-240v | AIH094 | FDA UDI | Class II | Active |
| Leadwire Blk 40"du/Sn | LSB005 | FDA UDI | Class II | Active |
| Patient Cable-5 Lead Du | KEC010 | FDA UDI | Class II | Active |
| Lamp (12vdc 100w) - 6 | LMP028 | FDA UDI | Class II | Active |
| Patient Cable-5 Lead Ml | KED021 | FDA UDI | Class II | Active |
| 3 Lw Set 30" Du/Sn Dp - 10 | LDM306 | FDA UDI | Class II | Active |
| Patient Cable-5 Ld Fix Pn | KEB014 | FDA UDI | Class II | Active |
| 5 Leadwire Set - 30" Ml/Sn | LKM056 | FDA UDI | Class II | Active |
| Skin Temp Probe (reusable) | OMP011 | FDA UDI | Class II | Active |
| 3 Lw Set 30" Du/Pi Dp - 10 | LDM312 | FDA UDI | Class II | Active |
| Patient Cable - 10 Ld Fixsn | KKB011 | FDA UDI | Class II | Active |
| Skin Temp Probe - 10 | AIP080 | FDA UDI | Class II | Active |
| 3 Leadwire Set - 24"dn/Sn | LKM005 | FDA UDI | Class II | Active |
| Patient Cable-5 Ld Fix Bn | KEB030 | FDA UDI | Class II | Active |
| Skin Temp Probe - 50 | OMP007 | FDA UDI | Class II | Active |
| Air Auxilary Probe (gp 1) | AIP070 | FDA UDI | Class II | Active |
| Patient Cable - 3 Lead Dn | KCA004 | FDA UDI | Class II | Active |
| Skin Temp Probe (reusable) | AIP063 | FDA UDI | Class II | Active |
| Acquisition Module Cable | GEC020 | FDA UDI | Class II | Active |
| 5 Leadwire Set - 24" Dn/Sn | LKM029 | FDA UDI | Class II | Active |
| Skin Temp Probe - 10 | OMP006 | FDA UDI | Class II | Active |
| 5 Leadwire Set - 24" Dn/Pi | LKM026 | FDA UDI | Class II | Active |
| Lamp | LMP018 | FDA UDI | Class II | Active |
| Patient Cable - 3 Lead Dn | KCA025 | FDA UDI | Class II | Active |
| 5 Leadwire Set - 30" Ml/Sn | LKM054 | FDA UDI | Class II | Active |
| Skin Temp Probe (reusable) | OMP008 | FDA UDI | Class II | Active |
| Leadwire Blu 24"dn/Sn | LSU002 | FDA UDI | Class II | Active |
| Patient Cable-5 Lead Du | KEC003 | FDA UDI | Class II | Active |
| 10 Leadwire Set - Cam14/Bn | LKM049 | FDA UDI | Class II | Active |
| Skin Temp Probe - 50 | OMP010 | FDA UDI | Class II | Active |
| Skin Temp Probe - 100 | AIP101 | FDA UDI | Class II | Active |
| Air Auxilary Probe (gp 2) | AIP141 | FDA UDI | Class II | Active |
| Patient Cable - 10 Ld Fx Bn | KKB008 | FDA UDI | Class II | Active |
| Telemetry Cable 5 Lead Sn | KEB018 | FDA UDI | Class II | Active |
| Patient Cable-5 Lead Dn | KEA001 | FDA UDI | Class II | Active |
| Patient Cable - 3 Ld Fx Sn | KCB008 | FDA UDI | Class II | Active |
| 3 Lw Set 24" Dn/Pi Dp - 10 | LDM309 | FDA UDI | Class II | Active |
| 3 Leadwire Set - 24"dn/Sn | LKM011 | FDA UDI | Class II | Active |
| Skin Temp Probe (reusable) | AIP132 | FDA UDI | Class II | Active |
| Patient Cable - 10 Ld Fx Bn | KKB007 | FDA UDI | Class II | Active |
| Heater | OMH005 | FDA UDI | Class II | Active |
| Patient Cable - 10 Ld Fx Bn | KKB006 | FDA UDI | Class II | Active |
| Skin Temp Probe - 100 | AIP134 | FDA UDI | Class II | Active |
| Leadwire Blu 24"dn/Pi | LPU002 | FDA UDI | Class II | Active |
| Patient Cable-5 Ld Fix Sn | KEB012 | FDA UDI | Class II | Active |
| Patient Cable-5 Lead Du | KEC016 | FDA UDI | Class II | Active |
| Telemetry Cable 4 Lead Sn | KDB002 | FDA UDI | Class II | Active |
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