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EVA TPN Container

by B. Braun Medical, Inc.

510(k) K041415

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041415 Date4 Aug 2004ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1592-2022 FDA Class II initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KPE
FDA applicant
B.Braun Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 880.5025
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EVA TPN Container is a container, I.V., designed for the preparation and administration of Total Parenteral Nutrition (TPN) solutions. It is constructed from Ethylene Vinyl Acetate (EVA), a PVC- and DEHP-free material that reduces the risk of chemical leaching and contamination.

The device is supplied as a single-chamber bag and is available in two sizes. It is intended for use in healthcare settings for gravity transfer of TPN solutions. The EVA TPN Container received FDA 510(k) clearance (K041415) and is classified as a Class II medical device under regulation number 880.5025.

From the manufacturer

EVA Gravity Mixing Containers -. Compounding containers for basic transfer B. Braun offers single and dual chamber mixing containers for gravity transfer.

Source: bbraunusa.com

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