Portex
50 catalogue numbers from Z130-16, listed by ICU Medical, Inc, United States, under Nebulizer (Direct Patient Interface). 42 manufacturers in China are registered for this product code.
42manufacturers in China registered for this device type
50catalogue numbers in this listing
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 | ICU Medical, Inc, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K901315 |
| Record published | 2016-10-19 |
| Record revised | 2025-09-24 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 20, case of 10, case of 25, case of 50, box of 50, case of 5 |
| Distribution end date | 2019-11-20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Z130-16 | In distribution | ||
| 11-1121 | In distribution | ||
| Z120-14 | In distribution | ||
| 11-1050 | In distribution | ||
| 11-1122 | In distribution | ||
| 11-4120 | In distribution | ||
| Z135-16 | In distribution | ||
| 11-4100 | In distribution | ||
| 77-3100 | In distribution | ||
| Z130-14 | In distribution | ||
| 11-4140 | In distribution | ||
| 11-1060 | In distribution | ||
| Z110N-12 | In distribution | ||
| Z110-14 | In distribution | ||
| Z120-10 | In distribution | ||
| 002220 | In distribution | ||
| Z115N-12 | In distribution | ||
| Z116N-14 | In distribution | ||
| 11-4110 | In distribution | ||
| Z216-14 | In distribution | ||
| Z118-14 | In distribution | ||
| 11-1020 | In distribution | ||
| 11-1123 | In distribution | ||
| Z110-10 | In distribution | ||
| Z120N-14 | In distribution | ||
| 11-4130 | In distribution | ||
| 11-1070 | In distribution | ||
| Z118N-14 | In distribution | ||
| Z135-14 | In distribution | ||
| Z215-14 | In distribution | ||
| Z120-12 | In distribution | ||
| 11-1010 | In distribution | ||
| Z116-14 | In distribution | ||
| 11-1030 | In distribution | ||
| Z115-16 | In distribution | ||
| 11-1040 | In distribution | ||
| Z118N-16 | In distribution | ||
| Z120N-12 | In distribution | ||
| Z110N-10 | In distribution | ||
| 11-1120 | In distribution | ||
| Z120N-16 | In distribution | ||
| Z120-16 | In distribution | ||
| 4307SM | Withdrawn | ||
| 007760 | Withdrawn | ||
| 4432 | Withdrawn | ||
| 007767 | Withdrawn | ||
| 4100 | Withdrawn | ||
| R0059 | 100 | Withdrawn | |
| R0039 | 100 | Withdrawn | |
| 002223 | 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 |
| 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)
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.