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Dual Compartment TPN Bag 3 Liter

by Stedim, Inc.

510(k) K911567

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911567 Date2 Aug 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 880.5025
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Dual Compartment TPN Bag 3 Liter is a container for intravenous use with a dual compartment design. It is specifically designed for total parenteral nutrition (TPN) administration, containing separate compartments for amino acid solution without electrolytes and glucose solution without calcium.

This device is supplied as a single-use container and is regulated under FDA 510(k) clearance K911567 with product code KPE. It is manufactured by Stedim, Inc. and is intended for use in general hospital settings. The device is available in multiple sizes including CLINIMIX N12G20, CLINIMIX N14G30, and CLINIMIX N17G35.

Other devices from Stedim, Inc.

Questions

AI-generated answers, 27 Sep 2026

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

  • What is the Dual Compartment TPN Bag 3 Liter used for?

    The Dual Compartment TPN Bag 3 Liter is a container designed for intravenous use specifically for total parenteral nutrition (TPN) administration. It features separate compartments for amino acid solution without electrolytes and glucose solution without calcium.

  • Is the Dual Compartment TPN Bag reusable or single-use?

    This device is supplied as a single-use container and is not intended for reuse. It is designed for one-time administration of TPN solutions and should be discarded after use.

  • What sizes and models of the Dual Compartment TPN Bag are available?

    The device is available in multiple sizes including CLINIMIX N12G20, CLINIMIX N14G30, and CLINIMIX N17G35, providing options for different clinical requirements.

  • What is the regulatory status of the Dual Compartment TPN Bag 3 Liter?

    The device is regulated under FDA 510(k) clearance K911567 with product code KPE. It is manufactured by Stedim, Inc. and is intended for use in general hospital settings.