Venoset Multi-Med Piggyback W/Ivex-2
by Abbott Laboratories 510(k)
Active
510(k) K833740
Overview
The Venoset Multi-Med Piggyback with IVEX-2 is a Set, Administration, Intravascular device designed for intravenous (IV) medication administration. It features a multi-medication capability, allowing simultaneous or sequential infusion of multiple fluids or drugs through a single access port. The IVEX-2 component integrates a secondary infusion line, enabling piggyback administration of additional medications without interrupting the primary infusion.
This device is intended for use in general hospital settings and is supplied as a single-use, non-sterile item (unless terminally sterilized per packaging instructions). It is classified under FDA product code FPA and was granted FDA 510(k) clearance (K833740) in 1983 under Traditional review. Compliance with Class II – Special Controls applies, and its design adheres to regulatory standards for intravenous administration sets. Storage and handling follow standard medical device protocols to ensure integrity prior to use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833740 | Date27 Dec 1983 | 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- Withdrawn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 Venoset Multi-Med Piggyback with IVEX-2 used for?
This device is designed for intravenous (IV) medication administration in general hospital settings. It allows healthcare providers to deliver multiple fluids or drugs simultaneously or sequentially through a single access port, making it ideal for scenarios where multiple infusions are required without interrupting the primary line. The IVEX-2 component specifically enables piggyback administration, ensuring flexibility in medication delivery.
Is the Venoset Multi-Med Piggyback with IVEX-2 sterile?
The device is supplied as a single-use item and is classified as non-sterile unless terminally sterilized according to the packaging instructions. Always follow the manufacturer’s guidelines for sterilization and handling to ensure patient safety and device integrity before use.
How is the Venoset Multi-Med Piggyback with IVEX-2 supplied?
The set is supplied as a single-use device, meaning it is intended for one-time use only. This ensures patient safety and reduces the risk of contamination or cross-infection. Always check the packaging for terminal sterilization instructions before use.
Can this device be reused?
No, this device is explicitly designed for single-use only. Reusing intravenous administration sets poses significant risks, including infection and device malfunction, which could compromise patient care. Always adhere to single-use protocols as recommended by the manufacturer.
What storage and handling guidelines should be followed for the Venoset Multi-Med Piggyback with IVEX-2?
Storage and handling should follow standard medical device protocols to maintain the device’s integrity. Ensure the packaging remains intact until immediate use, and store in a clean, dry environment away from direct sunlight or extreme temperatures. Terminal sterilization instructions, if applicable, must be followed precisely to ensure the device is safe for use.