Bard Liberator Disposable Infusion System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K894292 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 Liberator Disposable Infusion System is a Class II infusion pump designed for controlled delivery of intravenous fluids and medications. It operates as a portable, battery-powered device to administer fluids at programmable rates, ensuring precise and continuous infusion therapy for patients in various clinical settings.
This system is intended for single-use and is supplied sterile, requiring no reprocessing. It is intended for use in general hospital settings and is compatible with standard intravenous lines and connectors. The device is regulated under FDA 510(k) clearance (K894292) and falls under the regulatory classification of FRN (Furniture, Repairs, and New). No MRI safety information or specific storage conditions are provided in the data.
Frequently asked questions
What clinical settings is the Bard Liberator Disposable Infusion System intended for use in, and how does this relate to its regulatory background?
The Bard Liberator Disposable Infusion System is designed for use in general hospital settings, as indicated by its regulatory submission to the General Hospital (HO) Advisory Committee. This classification reflects its intended application for controlled intravenous fluid and medication delivery in standard inpatient environments. The device’s FDA 510(k) clearance (K894292) under the Furniture, Repairs, and New (FRN) product code confirms its regulatory pathway, ensuring compliance for use in these clinical contexts.
Is the Bard Liberator Disposable Infusion System reusable, or is it meant for single-use only? How does this affect its handling?
The Bard Liberator Disposable Infusion System is explicitly intended for single-use only, requiring no reprocessing. This design ensures patient safety by eliminating risks associated with reuse, such as contamination or mechanical failure. Clinicians must adhere to single-patient use protocols and dispose of it after one administration cycle, as specified in the manufacturer’s instructions.
What types of intravenous lines and connectors is the Bard Liberator compatible with, and does it require any special preparation before use?
The Bard Liberator Disposable Infusion System is compatible with standard intravenous lines and connectors, meaning it integrates seamlessly with widely used hospital tubing and fittings. Since it is supplied sterile, no additional sterilization or preparation is required before use—simply attach it to a compatible IV line and program the desired infusion rate. This simplifies setup in clinical workflows.
Are there any specific storage requirements mentioned for the Bard Liberator Disposable Infusion System, or can it be stored under standard hospital conditions?
The provided data does not specify any unique storage conditions for the Bard Liberator Disposable Infusion System, implying it can be stored under standard hospital environmental conditions (e.g., room temperature, protected from direct sunlight). However, as with all medical devices, it should be kept in a clean, dry area away from contaminants until use, following general hospital protocols for sterile supplies.
How do I determine which model or variant of the Bard Liberator Disposable Infusion System is right for my facility, given the multiple FEI numbers listed?
The FEI numbers (e.g., 3009754410, 3008717264) listed in the data correspond to specific regulatory filings rather than distinct clinical models or sizes. These identifiers track submissions to the FDA but do not indicate differences in functionality, capacity, or compatibility. To select the appropriate system for your facility, consult the manufacturer’s technical specifications or local purchasing records, as all variants appear to share the same core design for general hospital use. If size or flow rate variations exist, they are not detailed in the provided data.
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: K894292 FDA 510(k) - BARD LIBERATOR DISPOSABLE INFUSION SYSTEM, BARD LIBERATOR DISPOSABLE INFUSION SYSTEM (K894292) — FDA 510(k ..., Bard Liberator Disposable Infusion System - Beudamed, PDF K894292 - Bard Liberator Disposable Infusion System, United States Attorney's Office for the [...] (via Public) / C.R. Bard ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K894292 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K894292 24 fields · synced Sep 19, 2026