Purifier, Air, Ultraviolet, Medical

Product Code: FRA

General Hospital Ultraviolet Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 880.6500


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as FRA

2594Purifier, Air, Ultraviolet, MedicalMedical Ultraviolet Air Purifier.

Total Product Life Cycle (TPLC) Devices

2594Purifier, Air, Ultraviolet, MedicalMedical Ultraviolet Air Purifier.

Pre-market Notifications for FRA

K223328PurgoAeroClean Technologies, Inc.
K213753PurgoAeroClean Technologies, LLC
K212824Bluezone Model RX-450 Air PurifierBluezone Products, Inc.
K212644Aura StormInvictus Lighting
K211194Molekule Air ProMolekule, Inc.
K211139CUBE Air PurifierSamsung Electronics Co., Ltd.
K203189AEROCURE-MDAerobiotix, Inc.
K202766EOS Air CleanerGuangzhou Ajax Medical Equipment Co., Ltd.
K202339Molekule Air Mini, Molekule Air Mini +Molekule, Inc.
K201220Aerus Medical Guardian,model F170AAerus Medical LLC
K200500Molekule Air Pro RXMolekule, Inc.
K161468Transformair Indoor Air PurifierTransformair, LLC
K133800ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLIHGI INDUSTIRES
K062716ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400ECO-RX, INC.
K052732ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30PABRACAIR, INC.

Global Unique Device Identification Database

00811095020145Purifier, Air, Ultraviolet, Medical
00811095020121Purifier, Air, Ultraviolet, Medical
00811095020114Purifier, Air, Ultraviolet, Medical
00811095020107Purifier, Air, Ultraviolet, Medical
00811095020091Purifier, Air, Ultraviolet, Medical
00811095020060Purifier, Air, Ultraviolet, Medical
00811095020053Purifier, Air, Ultraviolet, Medical
00811095020046Purifier, Air, Ultraviolet, Medical
00811095020039Purifier, Air, Ultraviolet, Medical
00818701020308Purifier, Air, Ultraviolet, Medical
00818701020544Purifier, Air, Ultraviolet, Medical
00818701020537Purifier, Air, Ultraviolet, Medical
00818701020520Purifier, Air, Ultraviolet, Medical
00860006514808Purifier, Air, Ultraviolet, Medical
00819355020218Purifier, Air, Ultraviolet, Medical

Maude Adverse Events

LS HEMA Y-TP BLD CLVHOSPIRA COSTA RICA LTD.2015-05-18
PLUM A+ PUMP - MEDNET WIRELESSHOSPIRA, INC.2005-12-06
GEMSTAR NON-DEHP TUBING PUMP SET-SLABBOTT LABS2004-11-23
IONIC BREEZE AIR FRESHNER FOR BATHROOMSSHARPER IMAGE2004-02-01
LIVING AIR XL-15 CLASSICALPINE INDUSTRIES, INC.2001-06-01
UNKOZONE GENERATORUNK1997-11-19
PANDA OZONE GENERATORUNKNOWN1994-02-01
LIVING AIR AIR PURIFIERCONTECH ENTERPRISES1993-08-28

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