Nebulizer (Direct Patient Interface)
MDI Adaptor for use with or without dosage counters -22 mm OD/ 11mm ID x 22mm ID (Flow OD to ID)
42manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
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 | Southmedic, Inc., Canada |
|---|---|
| FDA product code | CAF |
| Device type | Nebulizer (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K760489 |
| Record published | 2016-09-01 |
| Record revised | 2020-12-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2020-12-18 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SMDIA-1200 | MDI Adaptor for use with or without dosage counters – 22 mm OD x 15 mm ID / 22 mm OD x 15 mm ID | 25 | In distribution |
| SMDIA-1300 | MDI Adaptor for use with or without dosage counters – 15mm OD x 15mm ID (Flow OD to ID) | 25 | In distribution |
| SMDIA-1100 | MDI Adaptor for use with or without dosage counters -22 mm OD/ 11mm ID x 22mm ID (Flow OD to ID) | 25 | In distribution |
| SMDIA-1000 | MDI Adaptor for use with or without dosage counters -22 mm ID x 22mm OD/15mm ID (Flow ID to OD) | 25 | In distribution |
| OAT-4025-8 | OxyTrach Mask Adult O2 Aerosol with Nebulizer Kit | 25 | Withdrawn |
| SMDIA-1100B | MDI Adaptor for use with or without dosage counters -22mm OD/15mm ID x 22mm ID (Flow OD to ID) | 200 | 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 |
|---|---|
| K101953 | 2011-01-07 |
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.