MiniMed Quick-serter

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Injector reset device

Device Name

MiniMed Quick-serter

Model / Reference

MMT-305QS

Primary DI / UDI-DI

00763000354817, 00763000573690

Basic UDI-DI

0763000B000004472

510(k) Number

K160860 ↗

FDA Product Code

KZH

EMDN Code

Z12040180 General medicine diagnosis and monitoring instruments - hardware accessories

GMDN Term

Injector reset device

Device Class

Class I EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 880.6920

EU market of registration

Netherlands

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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See all devices from Medtronic Minimed, Inc. →

• What clinical settings is the MiniMed Quick-Set designed for, and how does its single-use nature impact its use?

  The MiniMed Quick-Set is specifically designed for use in general hospital settings, as indicated by its registration and advisory committee classification. Since it is intended for single-use only, each device must be discarded after one use to maintain sterility and ensure patient safety. This design aligns with clinical practices where reusable devices may pose higher infection risks, particularly in environments with multiple patients or shared equipment.

• How many different sizes or configurations of the MiniMed Quick-Set are available, and how can I identify them?

  The MiniMed Quick-Set comes in multiple sizes and configurations, as evidenced by the extensive list of FEI numbers (e.g., 3002806521, 3013188547) and registration numbers (e.g., 9681821, 2032227) in the regulatory data. These identifiers correspond to distinct models, which may vary in needle gauge, length, or attachment mechanism. To determine the correct size for your patient, refer to the manufacturer’s guidelines or consult Medtronic’s product documentation, as these details are not specified in the public registry.

• Is the MiniMed Quick-Set sterile, and what precautions should be taken during handling to preserve its sterility?

  Yes, the MiniMed Quick-Set is supplied sterile for single-use in clinical settings. To maintain sterility, it must be handled using aseptic techniques, such as wearing gloves, avoiding direct contact with surfaces, and following the manufacturer’s instructions for opening and insertion. Sterility is critical for preventing infections, especially in continuous subcutaneous insulin delivery systems where skin contact is prolonged.

• What regulatory pathways does the MiniMed Quick-Set follow, and how does this affect its availability?

  The MiniMed Quick-Set has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with U.S. and EU regulatory standards. These pathways ensure the device meets safety and performance requirements before market release. Availability is governed by these approvals, meaning it is legally distributed in regions where these clearances apply, such as the U.S. and EU, though specific distribution channels may vary by country.