Avi Model 4225 Vented Piggyback IV Admin Set
by 3M Avi, Inc.
510(k) K912069
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912069 | Date14 Oct 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 1 Oct 2026
The AVI Model 4225 Vented Piggyback IV Administration Set is a vented piggyback intravenous administration set designed for secondary fluid infusion. It facilitates the controlled delivery of medications or solutions into a primary IV line, allowing simultaneous administration of multiple fluids without cross-contamination. The vented design prevents pressure buildup, ensuring stable flow rates and reducing the risk of air embolism. This device is classified under product code FPA and is intended for use in general hospital settings.
This IV administration set is supplied as a single-use, non-sterile device (unless terminally sterilized per manufacturer specifications) and is intended for one-time clinical use. It features an 83-inch length and a priming volume of 17 mL, with a drip chamber calibrated at 10 drops per mL. The device has received FDA 510(k) clearance (K912069) under a traditional review pathway, with a decision of Substantially Equivalent to the predicate device. Storage should follow manufacturer guidelines to maintain integrity, and compatibility with MRI environments is not specified.
Other devices from 3M Avi, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the AVI Model 4225 Vented Piggyback IV Administration Set used for?
This device is designed for secondary fluid infusion in a primary IV line, allowing simultaneous administration of medications or solutions without cross-contamination. The vented design ensures stable flow rates by preventing pressure buildup, which also reduces the risk of air embolism—a critical safety feature for hospital patients requiring multiple infusions.
Is the AVI 4225 supplied sterile, and how is it intended for use?
The AVI Model 4225 is supplied as a single-use device, but its sterility depends on terminal sterilization per manufacturer specifications. It is explicitly intended for one-time clinical use only, ensuring patient safety and preventing contamination from reuse.
What are the key specifications of the AVI 4225, including length and drip chamber calibration?
The set features an 83-inch length for flexibility in patient positioning, with a priming volume of 17 mL to minimize dead space. The drip chamber is calibrated at 10 drops per milliliter, providing precise flow control for secondary infusions. These specifications help clinicians achieve accurate medication delivery while maintaining stability.
How should the AVI 4225 be stored to maintain its integrity?
Storage instructions are provided by the manufacturer to preserve the device’s integrity, though specific details (e.g., temperature, humidity, or packaging) are not included in the data. Adhering to these guidelines ensures the set remains functional and safe for its intended single-use application.
Does the AVI 4225 have any compatibility considerations, such as MRI environments?
The data does not specify compatibility with MRI environments, so clinicians should verify compatibility with their facility’s MRI protocols before use. Since the device is primarily intended for general hospital settings, additional testing may be required if MRI exposure is anticipated.