PRN Plus Infusion Set
510(k) K884053
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884053 | Date31 Oct 1988 | 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- Withdrawn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 PRN Plus Infusion Set is a peripheral intravenous infusion device designed for administering fluids, medications, or nutrients directly into a patient’s peripheral vein. It consists of a set of tubing, connectors, and a spike for attaching to a fluid container, facilitating controlled delivery of therapeutic solutions. This device is intended for short- to intermediate-term use in clinical settings such as hospitals, clinics, or home healthcare environments.
The PRN Plus Infusion Set is supplied as a single-use, non-sterile device, requiring terminal sterilisation prior to use. It is compatible with standard intravenous administration systems and must be handled under aseptic conditions to prevent contamination. The device is regulated under FDA 510(k) clearance (K884053) and falls under the product code FPA, classified under the General Hospital advisory committee. Storage and handling instructions must adhere to manufacturer guidelines to ensure proper functionality and patient safety.
Other devices from Prn Services, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the PRN Plus Infusion Set used for?
The PRN Plus Infusion Set is designed for administering fluids, medications, or nutrients directly into a patient’s peripheral vein. It is intended for short- to intermediate-term use in clinical environments like hospitals, clinics, or home healthcare settings. The device ensures controlled delivery of therapeutic solutions through its tubing, connectors, and spike system.
Is the PRN Plus Infusion Set sterile as supplied?
No, the PRN Plus Infusion Set is supplied as a non-sterile device. It must undergo terminal sterilization before use to ensure sterility and prevent contamination. Always follow aseptic handling procedures during preparation.
Can the PRN Plus Infusion Set be reused?
No, the PRN Plus Infusion Set is intended for single-use only. Reusing the device poses risks of contamination and compromised functionality, which could affect patient safety. Always use a new set for each patient or infusion.
What are the key components of the PRN Plus Infusion Set?
The PRN Plus Infusion Set includes tubing, connectors, and a spike for attaching to a fluid container. These components work together to facilitate the controlled delivery of intravenous solutions, ensuring compatibility with standard administration systems.
How should the PRN Plus Infusion Set be stored?
The PRN Plus Infusion Set must be stored according to the manufacturer’s guidelines to maintain its integrity and functionality. Proper storage conditions help prevent damage and ensure the device remains suitable for use when terminally sterilized. Always refer to the provided instructions for specific storage requirements.