Kangaroo Enteral Feeding Syringes With ENFit Connector
FDA 510(k)Class II (US FDA 510(k))
by Covidien
Identifiers
- 510(k) Number
- K142128 FDA 510(k)
- FDA Product Code
- PNR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Kangaroo Enteral Feeding Syringes With ENFit Connector is an enteral syringe with an enteral specific connector. It is designed for the administration of fluids via enteral access devices.
The device is used in clinical or home care settings by clinicians or laypersons under clinician supervision. It features a female ENFit connector that interfaces with enteral access devices to prevent misconnections and ensure secure, enteral-specific attachment. The product is supplied non-sterile and is intended for single use. It is regulated under FDA 510(k) clearance K142128 as a Class II device with product code PNR and regulation number 876.5980.
Frequently asked questions
What is the Kangaroo Enteral Feeding Syringe With ENFit Connector used for?
It is designed for the administration of fluids via enteral access devices in clinical or home care settings by clinicians or laypersons under clinician supervision, ensuring secure, enteral-specific attachment to prevent misconnections.
Is the Kangaroo Enteral Feeding Syringe sterile or non-sterile, and is it intended for single use or reuse?
The device is supplied non-sterile and is intended for single use only, as stated in the device description, to ensure patient safety and prevent cross-contamination during enteral feeding procedures.
What regulatory pathway was used for the Kangaroo Enteral Feeding Syringe With ENFit Connector, and what is its classification?
The device was cleared through the FDA 510(k) pathway under submission K142128 and is classified as a Class II medical device with product code PNR and regulation number 876.5980.
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: Kangaroo - Wikipedia, ENFit™ Connector - Enteral Feeding Connections | Cardinal Health, Kangaroo Enteral Feeding Syringes With Enfit Connector, PDF Kangaroo Nutritional Delivery ENFit Products - Cardinal Health
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142128 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien
Sources (1)
- FDA 510(k) K142128 24 fields · synced Sep 21, 2026