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Modified Eva-Mix and Di-Mix Bags

by Gil-Med Industries C/O Kegan & Kegan, Ltd.

510(k) K880506

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 NumberK880506 Date20 May 1988ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

Modified Eva-Mix and Di-Mix Bags are containers for intravenous (I.V.) use, classified as a Class II medical device under FDA regulation. The device is substantially equivalent to a legally marketed predicate device, as determined through the traditional 510(k) clearance pathway.

The device was cleared by the FDA on May 20, 1988, under K880506, and is manufactured by Gil-Med Industries C/O Kegan & Kegan, Ltd. It is intended for general hospital use and is supplied as a non-sterile, reusable or single-use container depending on clinical protocol, with no MRI safety information provided in the data. Storage and handling should follow manufacturer guidelines, and the device is authorized for distribution in the United States.

Other devices from Gil-Med Industries C/O Kegan & Kegan, Ltd.