Nebulizer (Direct Patient Interface)
NebuTech® HDN® Nebulizer with inhalation and exhalation valve, universal mask adaptor, mouthpiece, 14’ (4.2 m) supply tube
42manufacturers in China registered for this device type
23catalogue numbers in this listing
9510(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.
| 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 | Salter Labs, United States |
|---|---|
| FDA product code | CAF |
| Device type | Nebulizer (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K962879 |
| Record published | 2016-09-24 |
| Record revised | 2026-06-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Storage environment temperature -15 to 50 °C |
| Packaging | Pack of 50, pack of 25, pack of 10, pack of 30, pack of 35, pack of 12 |
| Distribution end date | 2018-07-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SO-1753-0 | In distribution | |
| SO-964BY | In distribution | |
| 8980-0 | Adult | In distribution |
| 1302-0-10 | In distribution | |
| 8960-7 | Adult | In distribution |
| 1233-0-10 | In distribution | |
| SO-1963-0 | Adult | In distribution |
| SO-1735GN | In distribution | |
| 1230 | In distribution | |
| M834335 | Adult | In distribution |
| 8975-0-50 | Adult | In distribution |
| 1301-0-10 | In distribution | |
| 8982TG-7 | Pediatric | In distribution |
| 8680-0 | Adult | In distribution |
| 8685-0 | In distribution | |
| SO-433 | In distribution | |
| 8960-PEP-7 | Adult | In distribution |
| SO-478BE | In distribution | |
| 8970-0-50 | In distribution | |
| 8960-14 | Adult | In distribution |
| 8661 | Adult | In distribution |
| SO-923BE | In distribution | |
| SO-975RD | Withdrawn |
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 |
|---|---|
| K014056 | 2002-02-01 |
| K992285 | 2000-01-07 |
| K992986 | 1999-09-24 |
| K991788 | 1999-08-06 |
| K983403 | 1998-12-17 |
| K962879 | 1996-10-22 |
| K962085 | 1996-08-26 |
| K961476 | 1996-07-16 |
| K884947 | 1989-02-17 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | 510(k) number | 2015-08-04 | Class II | Component change control | The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment. | 8,975 | 2016-05-06 |
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.