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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 the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2024-01-04 under 510(k) 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. The listed applicant is Medline Industries, LP. The 510(k) number is K231058.

When did Hudson RCI® AddiPak® Unit Dose Vial receive FDA 510(k) clearance?

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

Who is the listed applicant for Hudson RCI® AddiPak® Unit Dose Vial?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

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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