Ventlab
Rigid Airial Chamber w/ Mask, Pkg in Medquip Box-Spanish
42manufacturers in China registered for this device type
56catalogue numbers in this listing
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.
| 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 | Ventlab, LLC, United States |
|---|---|
| FDA product code | CAF |
| Device type | Nebulizer (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| Record published | 2016-09-27 |
| Record revised | 2021-06-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: General Warehouse. Do not get wet. |
| Packaging | Box of 20, box of 50, box of 10, box of 165 |
| Sizes | Outer diameter 22 mm; length 7 ft |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MQ8100 | In distribution | |
| BR302 | Outer Diameter 22 mm | In distribution |
| br200-w | Outer Diameter 22 mm | In distribution |
| PRO-6212 | In distribution | |
| BR310 | In distribution | |
| br302-i | Outer Diameter 22 mm | In distribution |
| BR210 | Outer Diameter 22 mm | In distribution |
| PRO-6103 | In distribution | |
| MQ8001 | In distribution | |
| HCSA112 | In distribution | |
| PRO-6214 | In distribution | |
| PRO-6105 | In distribution | |
| BR205 | Outer Diameter 22 mm | In distribution |
| 301-062213G | In distribution | |
| BR203-I | Outer Diameter 22 mm | In distribution |
| BR305 | Outer Diameter 22 mm | In distribution |
| PRO-6118 | In distribution | |
| BR202-I | Outer Diameter 22 mm | In distribution |
| BR200 | Outer Diameter 22 mm | In distribution |
| HCSA100 | In distribution | |
| BR204-I | Outer Diameter 22 mm | In distribution |
| 4430120 | In distribution | |
| BR203 | Outer Diameter 22 mm | In distribution |
| BR220 | Outer Diameter 22 mm | In distribution |
| BR303 | Outer Diameter 22 mm | In distribution |
| PRO-6100 | In distribution | |
| BR301 | Outer Diameter 22 mm | In distribution |
| VHC100 | In distribution | |
| BR202 | Outer Diameter 22 mm | In distribution |
| BR300-50 | Outer Diameter 22 mm | In distribution |
| 5210 | Length 7 ft | In distribution |
| PRO-6104 | In distribution | |
| br330 | In distribution | |
| MQ8000 | In distribution | |
| PRO-6101 | In distribution | |
| 5110 | Length 7 ft | In distribution |
| MQ8000-B | In distribution | |
| HCSA114 | In distribution | |
| BR320 | In distribution | |
| hcsa113 | In distribution | |
| br304-i | Outer Diameter 22 mm | In distribution |
| 301-062213 | In distribution | |
| MQ8100S | In distribution | |
| 4430220 | In distribution | |
| PRO-6102 | In distribution | |
| br300 | Outer Diameter 22 mm | In distribution |
| PRO-6213 | In distribution | |
| PRO-6118-50 | In distribution | |
| br130 | In distribution | |
| BR204 | Outer Diameter 22 mm | In distribution |
| br120 | In distribution | |
| BR200-50 | Outer Diameter 22 mm | In distribution |
| BR304 | Outer Diameter 22 mm | In distribution |
| HCSA200 | In distribution | |
| br303-i | Outer Diameter 22 mm | In distribution |
| 5000 | Length 7 ft | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 220 |
| AirLife | Carefusion | 77 |
| AirLife™ | Airlife, Inc. | 76 |
| 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 |
| Medline | Medline Industries, Inc. | 38 |
Showing 12 of 541. All products under Nebulizer (Direct Patient Interface)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K090840 | 2009-06-25 |
| K981944 | 1998-08-24 |
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.