Level 1 L1-FILTER

• FDA 510(k) K181699 decided 26 Jul 2018 Active
• FDA GUDID UDI-DI 15019517100303 listed 9 Aug 2019 Listed

1. 26 Jul 2018 Cleared FDA 510(k) K181699
2. 9 Aug 2019 Listed FDA GUDID 15019517100303

Trade name

Level 1

Generic name

Non-respiratory device ambient air filter

Model / reference

L1-FILTER

Primary DI / UDI-DI

15019517100303

510(k) Number

K181699 ↗

FDA product code

DWJ

GMDN term

Non-respiratory device ambient air filter

Device class

Class II

Regulation number

870.5900

GUDID distribution status

In Commercial Distribution

Category: Non-respiratory device ambient air filter

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See all devices from ICU Medical, Inc. →