Aira 100592

• FDA 510(k) K071886 decided 27 Dec 2007 Active
• FDA GUDID UDI-DI 00810194400728 listed 10 Feb 2026 Listed

1. 27 Dec 2007 Cleared FDA 510(k) K071886
2. 10 Feb 2026 Listed FDA GUDID 00810194400728

Trade name

Aira

Generic name

Sterilization packaging, single-use

Model / reference

100592

Primary DI / UDI-DI

00810194400728

510(k) Number

K071886 ↗

FDA product code

FRG

GMDN term

Sterilization packaging, single-use

Device class

Class II

Regulation number

880.6850

GUDID distribution status

In Commercial Distribution

Other devices filed under FDA product code FRG (Wrap, Sterilization).

• HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap by Owens & Minor (O&M) Halyard, Inc.
• DURA BLUE STERILIZATION WRAP by Cardinal Health 200, LLC
• METAPAK MULTI-PURPOSE INSTRUMENT TRAY by Riley Medical, Inc.
• APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER by Advanced Sterilization Products, Inc.
• REUSABLE STERILCONTAINER FILTER MODEL #JK090 by AESCULAP, INC.
• KIMGUARD PROCEDURE TRAY by KIMBERLY-CLARK CORPORATION
• KIMGUARD ONE-STEP Sterilization Wrap by Kimberly-Clark Health Care
• HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS by Hinson and Hale Medical Technologies, Inc.
• VAL-U-WRAP CSR WRAP by American Convertors Div., American Pharmaseal
• CONVERTORS STERILIZATION WRAP by Baxter Healthcare Corp

• Aira 119132

  Class I

  GUDID on market

• Aira 119133

  Class I

  FDA 510(k) K172930 Active Cleared 13 Apr 2018 GUDID on market

• Aira 119134

  Class I

  FDA 510(k) K243441 Active Cleared 31 Jan 2025 GUDID on market

• Aira 119144

  Class I

  FDA 510(k) K192444 Active Cleared 31 Dec 2019 GUDID on market

See all devices from Aira, LLC →