Honeywell

Honeywell Flagship Ultrasonic Humidifier

Registry build 21.09.26
55manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall

Who Else Makes It

Concentrated in Guangdong (25), Zhejiang (9), Jiangsu (8). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KFZ
Manufacturer City Province Registered as Device types
Evereast Medical Products Group Co., Ltd. Changyuan Henan Contract manufacturer 30
Jiangsu Mcare Medical Co., Ltd. Danyang Jiangsu Contract manufacturer 11
Raymond (Panyu Nansha) Electrical Appliances Development Co., Ltd. Guangzhou Guangdong Contract manufacturer 2
Chuzhou Donlim Electrical Appliances Co., Ltd. Chuzhou Anhui Contract manufacturer 1
Xiamen BRI Environmental Industry Co., Ltd. Xiamen Fujian Contract manufacturer 1
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Ningbo Greetmed Medical Instruments Co., Ltd. Ningbo Zhejiang Specification developer 75
Shanghai MU Promotions Co., Ltd. Shanghai Shanghai Exporter 62
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
Ningbo Just Soon Industrial Limited Ningbo Zhejiang Repacker / relabeller 36
Shenzhen Eyco Technology Co., Ltd. Shenzhen Guangdong Manufacturer 27
Ningbo Hanyue Medical Technology Co., Ltd. Cixi Zhejiang Contract manufacturer 27

Showing 12 of 55. All 55 manufacturers in China registered for Humidifier, Non-Direct Patient Interface (Home-Use)

Record

Regulatory record for Honeywell
Listed by Kaz, Inc., United States
FDA product code KFZ
Device type Humidifier, Non-Direct Patient Interface (Home-Use)
Device class Class 1
Regulation 21 CFR 868.5460
Premarket notification Exempt
Record published 2021-09-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Packaging Case of 2, case

Catalogue Numbers

Catalogue numbers for Honeywell
Catalogue number Size Status
HUL900B In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Air Innovations Great Innovations, LLC 83
Honeywell KAZ USA, Inc. 80
Vicks KAZ USA, Inc. 65
Pure Enrichment Bear Down Consulting 28
Sunbeam Jarden Consumer Solutions 21
CVS Woonsocket Prescription Center, Incorporated 9
NanoVi ENG3 Corporation 6
Equate Wal Mart Stores, Inc 5
Bubble Humidifier Westmed, Inc. 5
AirLife™ SunMed Group Holdings, LLC 5
Protec KAZ USA, Inc. 4
Rite Aid Pharmacy Rite AID Corporation 4

Showing 12 of 43. All products under Humidifier, Non-Direct Patient Interface (Home-Use)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K950116 1995-02-10

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2003-04-15 Not classified Other Humidifiers may overheat. 110,000 units 2005-02-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer