Identifiers
- 510(k) Number
- K904890 FDA 510(k)
- FDA Product Code
- FRN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bard Alfentanil Infuser is a Pump, Infusion designed for the controlled delivery of alfentanil, an opioid analgesic, via intravenous infusion. It is classified as a Class II medical device and operates as a syringe-driven infusion pump, enabling precise dosing and continuous administration in clinical settings. This device is intended for use in general hospital environments, where patient-controlled or nurse-administered analgesia may be required. Its mechanism ensures accurate flow rates and minimizes manual intervention during prolonged infusions.
The device is supplied as a reusable infusion pump, intended for use in sterile environments such as operating rooms, recovery units, or intensive care settings. It is not MRI-compatible and must be used in non-magnetic areas. The pump is regulated under FDA 510(k) clearance (K904890) and falls under the regulatory category FRN (Furniture, Refrigeration, and Non-Electrical Medical Equipment). No specific sterility or single-use designation is noted in the data, though clinical practice dictates adherence to infection control protocols. Storage and handling should comply with manufacturer guidelines to maintain functionality and safety.
Frequently asked questions
What is the Bard Alfentanil Infuser used for?
The Bard Alfentanil Infuser is a syringe-driven infusion pump designed specifically for the controlled intravenous delivery of alfentanil, an opioid analgesic. It is intended for use in clinical environments like operating rooms, recovery units, or intensive care settings where patient-controlled or nurse-administered analgesia is required. Its mechanism ensures precise dosing and continuous administration, reducing the need for manual intervention during extended infusions.
Is the Bard Alfentanil Infuser single-use or reusable?
The Bard Alfentanil Infuser is supplied as a reusable infusion pump. While the device itself is not designated as single-use, clinical practice dictates strict adherence to infection control protocols to maintain sterility and safety during reuse in sterile environments such as operating rooms or recovery units.
Where should the Bard Alfentanil Infuser be used?
This device is intended for use in general hospital environments, particularly in areas where controlled opioid analgesia is required, such as operating rooms, recovery units, or intensive care settings. It must be used in non-magnetic areas due to its non-MRI compatibility, ensuring patient safety during procedures.
How is the Bard Alfentanil Infuser regulated?
The Bard Alfentanil Infuser is regulated under the FDA 510(k) clearance process, with the specific clearance number K904890. It falls under the regulatory category FRN (Furniture, Refrigeration, and Non-Electrical Medical Equipment) and was determined to be substantially equivalent to a predicate device. The device was reviewed by the General Hospital Advisory Committee.
What storage and handling guidelines should be followed for the Bard Alfentanil Infuser?
The Bard Alfentanil Infuser should be stored and handled according to the manufacturer’s guidelines to ensure functionality and safety. Since it is a reusable device, proper cleaning, maintenance, and sterilization protocols must be followed to prevent contamination and maintain performance. Always refer to the manufacturer’s instructions for detailed storage and handling procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BARD ALFENTANIL INFUSER (K904890) — FDA 510(k) | Innolitics, Bard Muscle Relaxant Infuser - Wood Library-Museum of Anesthesiology, Atracurium in the bard alfentanil pump - Springer, BARD Pump IV Infusion For Sale or Wanted - DOTmed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904890 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K904890 24 fields · synced Oct 1, 2026