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Sign in to claim this brandPATHEN MEDICAL LLC
US
Last updated May 26, 2026
What PATHEN MEDICAL LLC makes
Pathen Medical LLC manufactures intravenous administration tubing extension sets and peripheral vascular/subcutaneous catheters, including both standard and customised variants for medical use.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database.
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 Pathen Medical LLC manufacture?
Pathen Medical LLC specializes in two primary device categories: intravenous administration tubing extension sets and peripheral vascular/subcutaneous catheters. These devices are designed for medical use, including standard and customized variants, to facilitate safe and effective fluid administration or vascular access in clinical settings.
Where is Pathen Medical LLC based?
Pathen Medical LLC is based in the United States. The company’s location is relevant for regulatory compliance and device distribution within the US market.
Which regulatory registries list Pathen Medical LLC’s devices?
Pathen Medical LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II devices under FDA regulations, helping healthcare providers and regulators identify and verify the devices.
How are Pathen Medical LLC’s devices classified under FDA regulations?
Pathen Medical LLC’s devices, including intravenous tubing extension sets and peripheral vascular catheters, are classified as Class II under FDA regulations. This classification typically indicates moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- pathen.com
- —
- —
- [email protected]
- Phone
- 8773185421
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 042928915
Catalogue (58)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ps-84326 | PS-84326 | FDA UDI | Class II | Active |
| Pmg0100 | PMG0100 | FDA UDI | Class II | Active |
| Ps-84322 | PS-84322 | FDA UDI | Class II | Active |
| Pr-84214 | PR-84214 | FDA UDI | Class II | Active |
| Ps-84316 | PS-84316 | FDA UDI | Class II | Active |
| 002231 | 002231 | FDA UDI | Class II | Active |
| Fk20201e | FK20201E | FDA UDI | Class II | Active |
| Basn-60-150 | BASN-60-150 | FDA UDI | Class II | Active |
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