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…
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.
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.
| 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
| 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
| 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 number | Size | Status |
|---|---|---|
| HCM-86C | In distribution |
Same 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
| 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.