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Uni-Picc

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130034

by Health Line International Corporation

Identifiers

510(k) Number
K130034 FDA 510(k)
FDA Product Code
LJS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5970 FDA 510(k)
Regulation Number
880.5970 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The UNI-PICC is a Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, designed for sustained vascular access. It provides a reliable lumen configuration for administering intravenous therapies, including fluids, medications, and nutritional support over extended periods. Available in single, double, and triple lumen variants, it supports diverse clinical needs across adult, pediatric, and neonatal patients. Its construction ensures durability and compatibility with long-term use in central venous access applications.

The UNI-PICC is supplied as a sterile, single-use device and is intended for use in hospital settings, including general medical wards. It is classified as a Class II medical device under FDA regulations (880.5970) and holds a Traditional 510(k) clearance (K130034) for substantial equivalence to predicate devices. The catheter is non-magnetic and MRI-safe, though specific imaging protocols should be followed. Storage requires adherence to manufacturer guidelines to maintain sterility and integrity. No reusable variants are authorized.

Frequently asked questions

What is the UNI-PICC catheter used for?

The UNI-PICC is designed for sustained vascular access over 30 days, enabling the administration of intravenous fluids, medications, and nutritional support. Its durable construction and multiple lumen options (single, double, or triple) make it suitable for diverse clinical needs, including central venous access in adult, pediatric, and neonatal patients.

How is the UNI-PICC catheter supplied and what are its sterility and reuse requirements?

The UNI-PICC is supplied as a sterile, single-use device, ensuring patient safety and compliance with hospital infection control protocols. Only one use per catheter is authorized; no reusable variants are approved for this model.

What lumen configurations are available for the UNI-PICC?

The UNI-PICC is available in three lumen configurations: single, double, and triple. These options allow clinicians to select the most appropriate catheter based on patient needs, such as simultaneous administration of multiple therapies or monitoring of central venous pressure.

Is the UNI-PICC catheter MRI-safe and what precautions should be taken?

The UNI-PICC is non-magnetic and MRI-safe, but specific imaging protocols must be followed during MRI procedures to ensure patient safety. Always consult the manufacturer’s guidelines or radiology team for protocol details before imaging.

What storage guidelines should be followed to maintain the UNI-PICC’s sterility and integrity?

The UNI-PICC must be stored according to the manufacturer’s instructions to preserve sterility and device integrity. This includes proper packaging, protection from contamination, and adherence to expiration dates. Unopened catheters should be stored in a clean, dry environment away from direct sunlight or extreme temperatures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Health Line Medical Products - Catheter Manufacturer, Kits and Supplies, Product Category: PICC Lines - Health Line Medical Products, Health Line International Corporation: Vascular & IR Devices

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Health Line International Corporation

Sources (1)

  • FDA 510(k) K130034 24 fields · synced Oct 5, 2026