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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Manufacturer

Icu Medical, Inc.

Date Cleared

2026-03-20

(266 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Age Range

All

Reference & Predicate Devices

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The ClaveQS™ Bag is intended for compounding and administration of parenteral solutions. Medication transfer in and out of the ClaveQS™ Bag is done using aseptic technique.

Device Description

AI/ML Overview

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