← Back to catalogue

Unomedical Monica Infusion Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032854

by Unomedical A/S

Identifiers

510(k) Number
K032854 FDA 510(k)
FDA Product Code
FPA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Unomedical Monica Infusion Set is a subcutaneous infusion administration set designed to deliver medication, including insulin, from an external infusion pump. It consists of a tubing connector, an indwelling PTFE catheter, and a 27 gauge stainless steel introducer needle for subcutaneous insertion. This device serves as a physical conduit for continuous medication delivery in patients requiring long-term therapy.

The infusion set is supplied sterile and intended for single-use, connecting to external infusion pumps via its tubing connector. It is regulated under FDA 510(k) clearance (K032854) and is classified under product code FPA. The stainless steel introducer needle (AISI 304) facilitates subcutaneous insertion, ensuring proper positioning of the catheter for reliable medication administration. Storage and handling must comply with sterile medical device protocols.

Frequently asked questions

What types of medications can the Unomedical Monica Infusion Set deliver, and how is it connected to an infusion pump?

The Unomedical Monica Infusion Set is specifically designed to deliver medications subcutaneously, including insulin, from an external infusion pump. It connects to the pump via its tubing connector, acting as a conduit for continuous medication administration. The set includes a PTFE catheter and a 27-gauge stainless steel needle for insertion, ensuring proper placement under the skin.

Is the Unomedical Monica Infusion Set reusable, or is it meant for single-use only?

The Unomedical Monica Infusion Set is intended for single-use only. This is a standard practice for sterile medical devices to prevent contamination and ensure patient safety. After use, it should be discarded, and a new set should be used for subsequent infusions.

How should the Unomedical Monica Infusion Set be stored, and what precautions should be taken?

Since the infusion set is supplied sterile, it must be stored and handled according to sterile medical device protocols. This includes keeping it in its original packaging until ready for use, avoiding exposure to contaminants, and adhering to manufacturer guidelines to maintain sterility and integrity.

What materials are used in the construction of the Unomedical Monica Infusion Set, particularly for the needle?

The infusion set features a 27-gauge stainless steel introducer needle made from AISI 304 grade stainless steel, which is chosen for its durability and biocompatibility. This ensures reliable subcutaneous insertion while maintaining patient safety during use.

How is the Unomedical Monica Infusion Set regulated, and what does its FDA clearance status indicate?

The Unomedical Monica Infusion Set has received FDA 510(k) clearance (K032854), which means it has been determined to be substantially equivalent to a legally marketed device in terms of technology and safety. This clearance is specific to its use as a subcutaneous infusion administration set, particularly for continuous medication delivery like insulin therapy.

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: UNOMEDICAL MONICA INFUSION SET (K032854) — FDA 510 (k) | Innolitics, PDF A/S OCT 9 2003 51qk) - Food and Drug Administration, fda.innolitics.com, Unomedical Device S.A. de C.V. - 719428 - 01/08/2026 | FDA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Unomedical A/S

Sources (1)

  • FDA 510(k) K032854 24 fields · synced Sep 19, 2026