Energized Drug Container System
by Abbott Laboratories 510(k)
Active
510(k) K934119
Overview
The Energized Drug Container System is a medical device classified under the FDA’s product code FPA, designed to deliver and control the administration of drugs in a hospital setting. It incorporates an energized mechanism to ensure precise dosing and monitoring of intravenous or infusion therapies, enhancing patient safety and treatment accuracy.
This system is intended for use in general hospital environments and is supplied as a reusable device. It requires regulatory compliance with FDA 510(k) clearance (K934119) and is intended for single-patient or multi-patient use under sterile conditions. The device’s energized components must be maintained according to manufacturer guidelines, and its operation adheres to standard hospital protocols for drug administration.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934119 | Date9 Jun 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Energized Drug Container System used for?
The Energized Drug Container System is designed to deliver and control intravenous or infusion therapies in hospital environments. Its energized mechanism ensures precise dosing and real-time monitoring, which helps reduce human error and enhances patient safety during drug administration. This makes it ideal for critical care settings where accurate medication delivery is essential.
Is the Energized Drug Container System reusable or single-use?
This system is supplied as a reusable device, meaning it can be used for multiple patients as long as it is maintained according to the manufacturer’s guidelines. Reusability is supported under sterile conditions, ensuring compliance with hospital protocols for drug administration and infection control.
How is sterility maintained in the Energized Drug Container System?
The Energized Drug Container System is intended for use under sterile conditions, which means it must be handled and stored in a manner that prevents contamination. The device’s energized components and overall system should follow standard hospital sterilization and maintenance protocols to ensure safety and functionality for repeated use.
What regulatory clearance does the Energized Drug Container System have?
The Energized Drug Container System holds FDA 510(k) clearance under the reference number K934119. This clearance confirms that the device meets regulatory standards for safety and effectiveness as a substantially equivalent product to prior generations, specifically for use in general hospital environments.
Can the Energized Drug Container System be used for both single-patient and multi-patient applications?
Yes, the Energized Drug Container System is designed for both single-patient and multi-patient use, provided it is maintained and operated under sterile conditions. The system’s reusable nature allows for flexibility in hospital workflows, but proper cleaning, calibration, and storage are critical to ensure consistent performance and patient safety across uses.