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Sign in to claim this brandDirectmed, Inc.
US
Last updated May 25, 2026
What Directmed, Inc. makes
Directmed, Inc. manufactures single-use intravenous administration tubing extension sets and surgical irrigation tubing sets. These products are designed for sterile medical use in fluid administration and surgical procedures, ensuring compatibility with existing systems from brands like Fresnius Kabi and OTOMED.
The company’s devices fall under FDA-regulated Class I and Class II categories, with products listed in the FDA’s Unique Device Identification (UDI) database. The portfolio is authorised for commercial distribution in the United States.
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 Directmed, Inc. manufacture?
Directmed, Inc. specializes in single-use medical devices, specifically intravenous administration tubing extension sets and surgical irrigation tubing sets. These products are designed for sterile use in fluid administration and surgical irrigation procedures, ensuring compatibility with established systems from brands like Fresnius Kabi and OTOMED.
Where is Directmed, Inc. based, and what does that mean for its regulatory oversight?
Directmed, Inc. is based in the United States, meaning its devices fall under FDA regulatory jurisdiction. Since the company’s products are manufactured and distributed domestically, they must comply with U.S. medical device regulations, including classification under FDA categories like Class I or Class II.
Which regulatory registries or databases list Directmed, Inc.’s devices?
Directmed, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers and regulators to verify product details, such as manufacturer information and device classification.
How are Directmed, Inc.’s devices classified by the FDA?
Directmed, Inc.’s devices are classified under FDA categories Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
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
- 969484237
Catalogue (38)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fresnius Kabi AG | FK50060S | FDA UDI | Class II | Active |
| Otomed, Inc. | SP-4000 | FDA UDI | Class I | Active |
| HMG Distribution LLC | CV1 | FDA UDI | Class II | Active |
| HMG Distribution LLC | CV100B | FDA UDI | Class II | Active |
| Fresnius Kabi AG | FK50030S | FDA UDI | Class II | Active |
| DirectMed, Inc. | SM-007 | FDA UDI | Class II | Active |
| Otomed, Inc. | SP-3000 | FDA UDI | Class I | Active |
| Otomed, Inc. | SP-3000 | FDA UDI | Class I | Active |
| Otomed, Inc. | SP-4000 | FDA UDI | Class I | Active |
| Directmed, Inc. | DM-116 | FDA UDI | Class II | Active |
| DirectMed, Inc. | SM-007 | FDA UDI | Class II | Active |
| HMG Distribution LLC | CV1 | FDA UDI | Class II | Active |
| HMG Distribution LLC | CV300B | FDA UDI | Class II | Active |
| Marian Medical, Inc. | BMS-2135.17 | FDA UDI | Class II | Active |
| Directmed, Inc. | PME007NB | FDA UDI | Class II | Active |
| Directmed, Inc. | BMS-2135.17 | FDA UDI | Class II | Active |
| Directmed, Inc. | BMS-2135.17 | FDA UDI | Class II | Active |
| Grace Medical, Inc. | SP-3000 | FDA UDI | Class I | Active |
| Directmed, Inc. | PME007NB | FDA UDI | Class II | Active |
| Fresnius Kabi AG | FK20251E | FDA UDI | Class II | Active |
| Fresnius Kabi AG | FK20251E | FDA UDI | Class II | Active |
| Directmed, Inc. | DM-116 | FDA UDI | Class II | Active |
| Directmed, Inc. | PME007B | FDA UDI | Class II | Active |
| HMG Distribution LLC | CV200B | FDA UDI | Class II | Active |
| Grace Medical, Inc. | SP-4000 | FDA UDI | Class I | Active |
| HMG Distribution LLC | CV100B | FDA UDI | Class II | Active |
| Grace Medical, Inc. | SP-3000 | FDA UDI | Class I | Active |
| HMG Distribution LLC | CV300B | FDA UDI | Class II | Active |
| Fresnius Kabi AG | FK50060S | FDA UDI | Class II | Active |
| Grace Medical, Inc. | SP-4000 | FDA UDI | Class I | Active |
| Fresenius KABI AG | FK20203E | FDA UDI | Class II | Active |
| Fresnius Kabi AG | FK20255E | FDA UDI | Class II | Active |
| HMG Distribution LLC | CV200B | FDA UDI | Class II | Active |
| Marian Medical, Inc. | BMS-2135.17 | FDA UDI | Class II | Active |
| Directmed, Inc. | PME007B | FDA UDI | Class II | Active |
| Fresnius Kabi AG | FK50030S | FDA UDI | Class II | Active |
| Fresenius KABI AG | FK20203E | FDA UDI | Class II | Active |
| Fresnius Kabi AG | FK20255E | FDA UDI | Class II | Active |
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