K-number	K243652
Device name	Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE)
Applicant	Cardinalhealth
Product code	PNR
Device class	Class II
Decision date	Dec 19, 2024
Decision	Substantially Equivalent
Regulation	876.5980

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Monoject™ Enteral Syringe with ENFit Connector is a medical device used to deliver fluids orally or enterally into the gastrointestinal system. It functions as a dispenser, measuring device, and fluid transfer device intended for use in clinical or home care settings by laypeople under clinician supervision or by clinicians, across all age groups.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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