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Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection Tube

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K033682

by Laboratorios Grifols, S.a.

Identifiers

510(k) Number
K033682 FDA 510(k)
FDA Product Code
LHI FDA 510(k)
Models / Variants
Set Gri-Fill 2.0-1 Way FDA 510(k)EUDAMED
2.0-2 Ways FDA 510(k)EUDAMED
Luer Connection Tube FDA 510(k)EUDAMED

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 Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection Tube is a disposable fluid transfer set designed for pharmacy compounding. It facilitates precise fluid administration and transfer within the GRI-FILL 2.0 system, available in configurations with either one or two pathways and an optional Luer adapter for compatibility with standard connectors.

This device is supplied as a single-use item and is intended for use in general hospital settings. It includes tubing, a syringe, and a distributor, with no regulatory restrictions on MRI safety noted. The set is authorized under FDA 510(k) clearance (K033682) and meets MDR requirements, ensuring compliance with applicable medical device regulations.

Frequently asked questions

What is the Gri-Fill 2.0 fluid transfer set designed for, and how does it differ between the 1-way and 2-ways configurations?

The Gri-Fill 2.0 fluid transfer set is specifically designed for pharmacy compounding to enable precise fluid administration and transfer within the GRI-FILL 2.0 system. The 1-way configuration features a single pathway for fluid flow, while the 2-ways version includes two separate pathways, allowing for simultaneous or sequential transfer of multiple fluids. Both versions maintain compatibility with standard connectors via the optional Luer adapter.

Is the Gri-Fill 2.0 set reusable, or is it intended for single-use only?

The Gri-Fill 2.0 set is explicitly labeled as a disposable, single-use item. This design ensures sterility and safety for each use, preventing cross-contamination between patients or compounding sessions. Reuse is not recommended or supported by the manufacturer.

What components are included in the Gri-Fill 2.0 set, and how does the Luer connection tube enhance its functionality?

The set includes tubing, a syringe, and a distributor, all integrated into a cohesive system for fluid transfer. The Luer connection tube adds versatility by enabling compatibility with standard Luer-lock connectors, allowing seamless integration with other medical devices or systems that rely on this common interface.

Are there any MRI safety concerns with the Gri-Fill 2.0 set, and where is it primarily intended for use?

The manufacturer has noted no regulatory restrictions on MRI safety for the Gri-Fill 2.0 set, meaning it is considered safe for use in MRI environments if clinical protocols permit. It is primarily intended for general hospital settings, particularly in pharmacy compounding workflows, as indicated by its FDA 510(k) clearance under the *General Hospital* product code (LHI).

How is the Gri-Fill 2.0 set authorized for use, and what regulatory pathways does it follow?

The Gri-Fill 2.0 set is authorized through FDA 510(k) clearance (K033682) under the *Traditional* review pathway, with a decision of *Substantially Equivalent* to a predicate device. It also complies with MDR (Medical Device Regulation) requirements, ensuring adherence to both U.S. and EU regulatory standards. The clearance was filed under the *General Hospital* advisory committee (HO) and third-party review.

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: Set Gri-fill 2.0-1 Way; 2.0-2 Ways; Luer Connection Tube (K033682 ..., Set Gri-fill 2.0-1 Way; 2.0-2 Ways; Luer Connection Tube - Beudamed, SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE 510 (k ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Laboratorios Grifols, S.a.

Sources (2)

  • FDA 510(k) K033682 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026