AMSure Enteral Feeding Syringe with ENFit Tip

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.

Trade Name

AMSure® ENFit syringe

Model / Reference

ENS03, ENS601, ENS01, ENS100, ENS05, ENS10, ENS20

Primary DI / UDI-DI

10704411018261, 10704411018308, 10704411018254, 10704411018315, 10704411018278, 10704411018285, 10704411018292

Basic UDI-DI

B-10704411018261, B-10704411018308, B-10704411018254, B-10704411018315, B-10704411018278, B-10704411018285, B-10704411018292

510(k) Number

K171857 ↗

FDA Product Code

PNR

EMDN Code

A020108 Enteral feeding syringes

Device Class

Class I EUDAMED

Class II 510(k)

Regulation

21 CFR Part 876.5980

EU market of registration

Netherlands

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Amsino International, Inc. →

• What is the primary purpose of the AMSure Enteral Feeding Syringe with ENFit Tip, and why is the ENFit connector important?

  The AMSure Enteral Feeding Syringe with ENFit Tip is designed specifically for administering fluids through enteral feeding tubes in clinical settings like hospitals and home healthcare. The ENFit connector is a standardized design compliant with ISO 80369-3, which helps minimize misconnections and significantly improves patient safety during enteral nutrition delivery by ensuring the correct attachment to feeding tubes.

• Is the AMSure Enteral Feeding Syringe single-use or reusable, and how is it supplied?

  The AMSure Enteral Feeding Syringe is intended for single-use only in clinical environments. It is supplied sterile, ensuring it meets infection control standards for direct patient use without the need for reprocessing.

• What sizes or models of this syringe are available, and how can I identify them?

  The AMSure Enteral Feeding Syringe comes in multiple variants, each with a unique FEI number (e.g., 3013557562, 3000209995) for traceability. These reference codes help distinguish specific models, though exact volume capacities or other technical specifications are not detailed in the provided data. The syringe is designed to be compatible with various enteral feeding tube sizes, but the exact sizing would depend on the model in use.

• How should the AMSure Enteral Feeding Syringe be stored, and is there any special handling required?

  While the data does not specify storage conditions explicitly, the syringe is supplied sterile, so it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is single-use, it should remain unopened until use to maintain sterility and integrity. Always follow manufacturer guidelines for packaging to ensure proper preservation.

• What regulatory pathways does the AMSure Enteral Feeding Syringe follow, and how does this affect its use?

  The AMSure Enteral Feeding Syringe is regulated under FDA 510(k) clearance (K171857) and the Medical Devices Directive (MDD). This means it has undergone evaluation by regulatory authorities to ensure safety and performance for its intended use in administering fluids through enteral feeding tubes. The clearance confirms it is substantially equivalent to predicate devices, ensuring compliance with U.S. and EU standards for Class II medical devices.