EXEL I.V. Administration Set
by Exelint Intl. Co. 510(k)
Active
510(k) K010404
Overview
The EXEL I.V. Administration Set is an intravascular administration set designed to deliver fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. It includes components such as tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, and fluid delivery tubing. The device may also include the needle or catheter as part of its assembly.
The set features a Y injection site to accommodate multiple fluid sources and is available with vented or non-vented drip chamber options. It includes an occlusion clamp, roller clamp, and 78-inch priming volume tubing, with a drip rate of 60 drops per milliliter. The device is not made with natural rubber latex and is intended for single use in clinical settings. It is regulated under product code FPA and was authorized through the FDA 510(k) process with a substantial equivalence determination.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010404 | Date30 Aug 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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 Exelint Intl. Co.
Questions
What is the EXEL I.V. Administration Set used for?
It is designed to deliver fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. It supports multiple fluid sources via a Y injection site and includes components like a drip chamber, flow regulator, and infusion line filter.
How is the device supplied and what components does it include?
The set includes tubing, a flow regulator, a drip chamber (vented or non-vented options), an infusion line filter, an I.V. set stopcock, fluid delivery tubing, an occlusion clamp, and a roller clamp. It may also include the needle or catheter as part of its assembly.
Is the EXEL I.V. Administration Set sterile and for single use?
Yes, the device is intended for single use in clinical settings. While the provided data does not explicitly state sterility, single-use administration sets of this type are typically supplied sterile to ensure patient safety and prevent cross-contamination.
What are the key specifications of the tubing and drip rate?
The device features 78-inch priming volume tubing and a drip rate of 60 drops per milliliter. These specifications support precise fluid delivery and are standard for general infusion applications.
Does the device contain natural rubber latex?
No, the EXEL I.V. Administration Set is not made with natural rubber latex. This is important for patients with latex allergies and helps reduce the risk of allergic reactions during use.