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FDA 510(k)

Hudson RCI® AddiPak® Unit Dose Vial

K-Number: K231058 · 2024-01-04

ApplicantMedline Industries, LP
Decision Date2024-01-04
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hudson RCI® AddiPak® Unit Dose Vial is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2024-01-04 under approval number K231058. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hudson RCI® AddiPak® Unit Dose Vial?

Hudson RCI® AddiPak® Unit Dose Vial is a medical device that received FDA 510(k) clearance on 2024-01-04. It is manufactured by Medline Industries, LP. The 510(k) number is K231058.

When was Hudson RCI® AddiPak® Unit Dose Vial approved by the FDA?

Hudson RCI® AddiPak® Unit Dose Vial received FDA 510(k) clearance on 2024-01-04, under approval number K231058.

What company makes Hudson RCI® AddiPak® Unit Dose Vial?

Hudson RCI® AddiPak® Unit Dose Vial is manufactured by Medline Industries, LP.

What is the FDA product code for Hudson RCI® AddiPak® Unit Dose Vial?

The FDA product code for Hudson RCI® AddiPak® Unit Dose Vial is CAF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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