LifeShield Additive Piercing Pin
by Abbott Laboratories 510(k)
Active
510(k) K002006
Overview
The LifeShield Additive Piercing Pin is a medical device classified under the FDA product code FPA, designed for use in intravenous (IV) administration systems. It is intended to facilitate the addition of medications or solutions to flexible IV containers without disrupting the primary infusion flow. Constructed to ensure compatibility with IV set ports, this device is engineered to minimize contamination risks during additive procedures.
Supplied in packs of 48, the LifeShield Additive Piercing Pin is intended for single-use only and is manufactured without natural rubber latex. It is regulated under FDA 510(k) clearance (K002006) and falls under the General Hospital advisory committee classification. The device is distributed in sterile packaging, adhering to standard medical device sterility standards, and is intended for use in clinical settings where IV additive procedures are performed.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK002006 | Date10 Aug 2000 | 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- Withdrawn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 LifeShield Additive Piercing Pin used for?
The LifeShield Additive Piercing Pin is designed to facilitate the safe addition of medications or solutions to flexible intravenous (IV) containers during infusion. It allows clinicians to pierce the IV bag’s port without interrupting the primary flow, minimizing the risk of contamination or disruption to the patient’s treatment.
How is the LifeShield Additive Piercing Pin supplied and packaged?
The device is supplied in sterile packaging, ensuring compliance with medical device sterility standards. Each pack contains 48 pins, and the packaging is intended for single-use only to maintain sterility and prevent cross-contamination.
Is the LifeShield Additive Piercing Pin latex-free?
Yes, the LifeShield Additive Piercing Pin is manufactured without natural rubber latex, making it suitable for use in patients with latex sensitivities or allergies.
Can the LifeShield Additive Piercing Pin be reused?
No, the LifeShield Additive Piercing Pin is intended for single-use only. Reusing the device could compromise sterility and increase the risk of contamination or infection, which is why it is supplied in sterile packaging for one-time clinical use.
What regulatory pathway does the LifeShield Additive Piercing Pin follow?
The LifeShield Additive Piercing Pin has received FDA 510(k) clearance under the product code FPA, classified under the General Hospital advisory committee. This clearance confirms its substantial equivalence to a predicate device and compliance with FDA requirements for intravenous additive devices.