Nivo Nebulizer System
NIVO Pro-X Controller Kit-CANADA/TAIWAN
42manufacturers in China registered for this device type
17catalogue numbers in this listing
9510(k) clearances naming this product code
4recalls on this 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 | Aerogen Ltd, Ireland |
|---|---|
| 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) | K102240 |
| Record published | 2016-09-16 |
| Record revised | 2025-09-24 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment atmospheric pressure 450 to 1100 millibar; Storage environment temperature -20 to 60 °C |
| Distribution end date | 2024-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1079422 | Withdrawn | |
| 1082697 | Withdrawn | |
| 1082695 | Withdrawn | |
| KR1076302 | Withdrawn | |
| 1079421 | Withdrawn | |
| CN1076302 | Withdrawn | |
| 90-067 | Withdrawn | |
| 1082693 | Withdrawn | |
| 1082694 | Withdrawn | |
| 1079424 | Withdrawn | |
| 1079423 | Withdrawn | |
| 1098093 | Withdrawn | |
| 1076301 | Withdrawn | |
| 1082698 | Withdrawn | |
| 1082696 | Withdrawn | |
| 1076302 | Withdrawn | |
| 1117345 | 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 |
|---|---|
| K232507 | 2024-05-10 |
| K143719 | 2015-07-10 |
| K133360 | 2014-10-17 |
| K120939 | 2012-04-26 |
| K103635 | 2011-05-13 |
| K032849 | 2003-11-21 |
| K021175 | 2002-05-15 |
| K003022 | 2000-10-13 |
| K992831 | 2000-08-25 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-09-02 | Class II | Nonconforming Material/Component | Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had b | 36 power adapters | 2016-04-25 |
| 2014-09-02 | Class II | Nonconforming Material/Component | Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had b | 1,223 power adapters | 2016-04-25 |
| 2014-09-02 | Class II | Nonconforming Material/Component | Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had b | 2,421 power adapters | 2016-04-25 |
| 2014-09-02 | Class II | Nonconforming Material/Component | Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had b | 323 power adapters | 2016-04-25 |
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.