Pulmogine

The Pulmogine Vibrating Mesh Nebulizer is a small, handheld, internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Pulmogine…

Registry build 21.09.26

The Pulmogine Vibrating Mesh Nebulizer is a small, handheld, internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Pulmogine Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and mainly composed of a Main Unit and a Medication Reservoir. The Main Unit contains the control circuitry and the firmware to control the vibrating mesh module in the Medication Reservoir and is powered by 2 AA alkaline batteries or an AC adaptor. The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will be turned into aerosols. The prescribed medication is added into the reservoir with ten (10) ml of medication capacity, nebulized, and inhaled through the aerosol port. The Pulmogine Vibrating Mesh Nebulizer generates aerosol from liquid medication during turning on through pressing ON/OFF button and turning off when pressing ON/OFF button again, auto-turn off when no liquid detected, or 10-minute session completed. There are different LED lights to monitor the status and operating condition of the nebulizer: green indicates power on and normally working, yellow flash indicates low power caution, and constant yellow indicates shut-off due to too low power.

42manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (23), Jiangsu (7), Fujian (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAF
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Hangzhou Jinlin Medical Appliances Co., Ltd. Hangzhou Zhejiang Contract manufacturer 11
Shenzhen Huayan E-Commerce Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Shenzhen BI-Rich Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9
Respironics Medical Products (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Omron (Dalian) Co., Ltd. (Plant 1) Dalian Liaoning Contract manufacturer 7
Apex Medical (Kunshan) Corp. Kunshan Jiangsu Contract manufacturer 4
Dongguan Polygreen Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Living Science Co., Ltd. Suzhou Jiangsu Contract manufacturer 3

Showing 12 of 42. All 42 manufacturers in China registered for Nebulizer (Direct Patient Interface)

Record

Regulatory record for Pulmogine
Listed by Hcmed Innovations Co., Ltd., Taiwan
FDA product code CAF
Device type Nebulizer (Direct Patient Interface)
Device class Class 2
Regulation 21 CFR 868.5630
Establishment Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2022-11-30
Record revised 2026-02-10 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date, serial number
Storage Storage environment temperature -25 to 70 °C; Storage environment humidity 0 to 93 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 5 to 40 °C; Handling environment humidity 15 to 93 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal
Packaging Box

Catalogue Numbers

Catalogue numbers for Pulmogine
Catalogue number Size Status
HCM-86C In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hudson RCI Teleflex Medical LLC 220
AirLife Carefusion 77
AirLife™ Airlife, Inc. 76
Ventlab Ventlab, LLC 56
I-neb Respironics Respiratory Drug Delivery (Uk), Ltd. 55
Aerogen® Solo Nebulizer System Aerogen Ltd 53
Portex ICU Medical, Inc 50
Sidestream Respironics Respiratory Drug Delivery (Uk), Ltd. 48
Hudson RCI Medline Industries, Inc. 46
DeVilbiss DeVilbiss Healthcare LLC. 45
Drive Drive DeVilbiss Healthcare 42
Drivemedical Drive DeVilbiss Healthcare 40

Showing 12 of 541. All products under Nebulizer (Direct Patient Interface)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K250583 2025-06-20
K202171 2021-07-01

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