Perifix Pediatric Epidural Kit
510(k) K962696
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SEKD | NumberK962696 | Date3 Apr 1997 | StatusActive |
Recalls
-
- Terminated Z-0150-2016
Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CAZ
- FDA applicant
- B.Braun Medical, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5140
- Advisory committee
- Anesthesiology
- FDA decision
- SEKD
Overview
AI-generated summary, 1 Oct 2026
The Perifix Pediatric Epidural Kit is an Anesthesia Conduction Kit, designed for pediatric epidural anesthesia procedures. It provides a sterile, preassembled system of components—including catheters, needles, connectors, and associated accessories—specifically sized and configured for use in children. This kit facilitates the administration of local anesthetics or other medications for regional analgesia or anesthesia in pediatric patients, ensuring precise and controlled delivery during surgical or diagnostic interventions.
This kit is intended for single-use in clinical settings such as operating rooms, procedural suites, or pediatric intensive care units. Supplied sterile and packaged for one-time use, it adheres to ISO 80369-6 standards for connectors, ensuring compatibility and safety. The device is classified under FDA regulation 868.5140 and holds a 510(k) clearance, confirming its compliance with U.S. regulatory requirements. No reusable components are included, and its design excludes MRI-compatible materials.
From the manufacturer
Continuous Epidural Trays (Kits) -. As the U.S. market leader in regional anesthesia, 1 B. Braun offers the broadest variety of standard epidural sets, as well as standard/custom single dose and continuous epidural tray configurations—with the quality you trust.
Continuous Pediatric Epidural Sets -. As the world leader in epidural products, and the leading supplier of epidural trays in North America, B. Braun offers the broadest variety of standard line epidural sets, along with single dose and continuous epidural tray configurations — with the quality you trust.
Other devices from B. Braun Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Perifix Pediatric Epidural Kit used for?
The Perifix Pediatric Epidural Kit is designed specifically for pediatric epidural anesthesia procedures. It provides a sterile, preassembled system of components—including catheters, needles, connectors, and accessories—tailored for use in children. This kit enables the controlled administration of local anesthetics or other medications for regional analgesia or anesthesia during surgical or diagnostic interventions in pediatric patients.
Is the Perifix Pediatric Epidural Kit single-use or reusable?
The Perifix Pediatric Epidural Kit is intended for single-use only. It is supplied sterile and packaged for one-time clinical use, ensuring safety and compliance with medical standards. No reusable components are included in the kit.
What sizes or models are available for the Perifix Pediatric Epidural Kit?
The Perifix Pediatric Epidural Kit is specifically sized and configured for pediatric patients. While exact model variations are not detailed in the provided data, the kit is designed to accommodate the anatomical and procedural needs of children, ensuring precise and safe administration of medications. For specific model references or additional sizing details, consult the manufacturer’s documentation.
How should the Perifix Pediatric Epidural Kit be stored?
The kit is supplied sterile and packaged for single-use, so it should be stored in its original, unopened packaging in a clean, dry environment, protected from contamination and physical damage. Follow the manufacturer’s instructions for storage conditions, including temperature and humidity guidelines, to maintain sterility and functionality until use.
Does the Perifix Pediatric Epidural Kit include MRI-compatible materials?
No, the Perifix Pediatric Epidural Kit does not include MRI-compatible materials. This design choice ensures safety and reliability for its intended use in clinical settings like operating rooms or procedural suites, where MRI compatibility is not required for epidural procedures.