Curaplex
Closed Dilution Nebulizer,barrel Standard Flow UP TO 12LPM, With 500ML Bottle Combination
42manufacturers in China registered for this device type
26catalogue numbers in this listing
5510(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 | Pegasus Research Corp., United States |
|---|---|
| FDA product code | CAF |
| Device type | Nebulizer (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| 510(k) | K962534 |
| Record published | 2021-09-15 |
| Record revised | 2025-09-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Case of 40, case of 20, pack of 40 |
| Sizes | Height 2 to 4.5 in; outer diameter 2.5 to 4 in; length 12 to 16 in; weight 1 to 3 lb |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 301-P3000HB | Height 3.5 in | In distribution |
| 301-P2001 | Outer Diameter 4 in | In distribution |
| 301-P3000N-L | Length 16 in | In distribution |
| 301-P3000N | Outer Diameter 2.5 in | In distribution |
| 301-P3000N-S | Length 12.5 in | In distribution |
| 301-P26000CF | Height 4.5 in | In distribution |
| P3000HC-S | Length 12.5 in | In distribution |
| 301-P3000HCF-S | Length 12.5 in | In distribution |
| P3000HC-L | Length 16 in | In distribution |
| P3000BHC | Height 3.5 in | In distribution |
| 301-P26000 | Height 4.5 in | In distribution |
| 301-P3000HCF | Outer Diameter 2.5 in | In distribution |
| 301-P3100H | Length 14.5 in | In distribution |
| 301-P3000NB | Outer Diameter 2.5 in | In distribution |
| 301-P2001CF | Outer Diameter 4 in | In distribution |
| 301-P3000NCF | Outer Diameter 2.5 in | In distribution |
| 301-P3000NCF-S | Length 12.5 in | In distribution |
| 301-P26200 | Outer Diameter 4 in | In distribution |
| 301-P3000CD | Height 3.5 in | In distribution |
| 301-P3100H-L | Length 16 in | In distribution |
| 301-P3000HCF-L | Length 16 in | In distribution |
| 301-P26100 | Outer Diameter 4 in | In distribution |
| 301-P3000NCF-L | Length 16 in | In distribution |
| 301-P2000 | Weight 3 lb | In distribution |
| 301-P3000H | Outer Diameter 2.5 in | In distribution |
| 301-P3100N | Height 3.5 in | 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 |
|---|---|
| K122857 | 2012-11-07 |
| K962534 | 1997-02-28 |
| K914465 | 1992-03-31 |
| K893942 | 1989-08-28 |
| K880473 | 1988-03-31 |
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.