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Sign in to claim this brandNDC HOMECARE LLC
US
Last updated May 23, 2026
What NDC HOMECARE LLC makes
NDC HomeCare LLC manufactures elastomeric infusion pump systems designed for continuous, non-electrical medication delivery, as well as basic intravenous administration sets for noninvasive fluid administration. The MediFlo line includes devices tailored for portable, ambulatory use in homecare settings, supporting controlled infusion of liquids without the need for external power sources. These products are intended for use in managing hydration, pain relief, or antibiotic therapy outside of clinical environments.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. All products comply with U.S. medical device requirements, ensuring adherence to safety and performance standards for infusion and administration systems. The manufacturer operates within the United States, aligning its portfolio with domestic regulatory frameworks.
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 NDC HomeCare LLC manufacture?
NDC HomeCare LLC specializes in two primary device categories: elastomeric infusion pump systems and basic intravenous administration sets for noninvasive use. The elastomeric infusion pumps are designed for continuous, non-electrical medication delivery, ideal for portable or ambulatory settings like homecare. The intravenous administration sets are used for fluid administration without invasive procedures. Both are tailored for managing hydration, pain relief, or antibiotic therapy outside clinical environments.
Where is NDC HomeCare LLC based, and how does that affect its devices?
NDC HomeCare LLC is based in the United States, which means its devices are developed and regulated under U.S. medical device standards. This includes compliance with FDA requirements, ensuring safety, performance, and quality for infusion and administration systems. The company’s domestic focus aligns its products with the regulatory frameworks governing medical devices in the U.S.
Which regulatory registries or databases list NDC HomeCare LLC’s devices?
NDC HomeCare LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II medical devices, including infusion pumps and intravenous administration sets, by assigning a standardized identifier to each product. Listing in the UDI database helps healthcare providers and regulators verify device details and compliance.
How are NDC HomeCare LLC’s devices classified under FDA regulations?
NDC HomeCare LLC’s devices are classified as Class II under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. For example, infusion pumps and intravenous administration sets fall under Class II due to their role in delivering medications or fluids, requiring validation of performance and labeling to mitigate risks like improper dosing or contamination.
What is the primary purpose of the MediFlo line of devices produced by NDC HomeCare LLC?
The MediFlo line is designed for portable, ambulatory use in homecare settings, focusing on controlled infusion of liquids without external power sources. These elastomeric infusion pumps are intended for continuous medication delivery, such as hydration, pain relief, or antibiotic therapy, outside of clinical environments. Their noninvasive and portable nature makes them suitable for patients requiring long-term or flexible treatment options at home.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 939966016
Catalogue (31)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MediFlo | MDL270010 | FDA UDI | Class II | Active |
| MediFlo | MDL270001 | FDA UDI | Class II | Active |
| MediFlo | MDE100500 | FDA UDI | Class II | Active |
| MediFlo | MDC300060 | FDA UDI | Class II | Active |
| MediFlo | MDE251750 | FDA UDI | Class II | Active |
| MediFlo | MDE250100 | FDA UDI | Class II | Active |
| MediFlo | MDE401000 | FDA UDI | Class II | Active |
| MediFlo | MDE402000 | FDA UDI | Class II | Active |
| MediFlo | MDC270010 | FDA UDI | Class II | Active |
| MediFlo | WP-MDL300060 | FDA UDI | Class II | Active |
| MediFlo | MDE050500 | FDA UDI | Class II | Active |
| MediFlo | MDE250500 | FDA UDI | Class II | Active |
| MediFlo | MDL270002 | FDA UDI | Class II | Active |
| MediFlo | WP-MDE102000-5 | FDA UDI | Class II | Active |
| MediFlo | MDE250125 | FDA UDI | Class II | Active |
| MediFlo | WP-MDE101000-5 | FDA UDI | Class II | Active |
| MediFlo | MDC100020 | FDA UDI | Class II | Active |
| MediFlo | MDE252500 | FDA UDI | Class II | Active |
| MediFlo | MDE200100 | FDA UDI | Class II | Active |
| MediFlo | MDC270050 | FDA UDI | Class II | Active |
| MediFlo | MDL500020 | FDA UDI | Class II | Active |
| MediFlo | MDE271750 | FDA UDI | Class II | Active |
| MediFlo | MDL100002 | FDA UDI | Class II | Active |
| MediFlo | MDE200200 | FDA UDI | Class II | Active |
| MediFlo | MDC270020 | FDA UDI | Class II | Active |
| MediFlo | MDL270005 | FDA UDI | Class II | Active |
| MediFlo | MDE102000 | FDA UDI | Class II | Active |
| MediFlo | MDE250050 | FDA UDI | Class II | Active |
| MediFlo | MDE101000 | FDA UDI | Class II | Active |
| MediFlo | MDE502500 | FDA UDI | Class II | Active |
| Wolf-Pak | RF5000 | FDA UDI | Class II | Active |
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