Portex
42 catalogue numbers from 20-3115, listed by ICU Medical, Inc, United States, under Spirometer, Therapeutic (Incentive). 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
42catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Ainengke Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Chinamed Products (China) Ltd. | Gaoyao District | Guangdong | Manufacturer | 8 |
| Shenzhen Gwode Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 2 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | BWF |
| Device type | Spirometer, Therapeutic (Incentive) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5690 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K760762 |
| Record published | 2016-10-11 |
| Record revised | 2025-04-17 (version 6) |
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 |
| Packaging | Case of 10, case of 12, case of 50, box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20-3115 | In distribution | |
| 21-5530 | In distribution | |
| 21-7530 | In distribution | |
| 22-2500 | In distribution | |
| 27-0050 | In distribution | |
| 23-6000 | In distribution | |
| 23-0747 | In distribution | |
| 27-9001 | In distribution | |
| 20-0022 | In distribution | |
| 23-2747 | In distribution | |
| 27-8000 | In distribution | |
| 27-9000 | In distribution | |
| 20-0050 | In distribution | |
| 20-1110 | In distribution | |
| 27-7000 | In distribution | |
| 20-0005 | In distribution | |
| 20-1112 | In distribution | |
| 23-3747 | In distribution | |
| 27-7000CN | In distribution | |
| 27-8050 | In distribution | |
| 21-3530 | In distribution | |
| 20-3112 | In distribution | |
| 20-5115 | In distribution | |
| 22-2501 | In distribution | |
| 21-7015 | In distribution | |
| HCS277000 | In distribution | |
| 22-1200 | In distribution | |
| 20-7115 | In distribution | |
| 21-3015 | In distribution | |
| 27-7001 | In distribution | |
| 23-1747 | In distribution | |
| 21-5015 | In distribution | |
| 20-0120 | In distribution | |
| 20-0010 | In distribution | |
| 20-5112 | In distribution | |
| 21-1530 | In distribution | |
| 22-4000 | In distribution | |
| 21-1015 | In distribution | |
| 23-0757 | In distribution | |
| 22-4001 | In distribution | |
| 20-7112 | In distribution | |
| 002000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 26 |
| AirLife™ | Airlife, Inc. | 11 |
| AIM | Vitalograph Ireland Ltd. | 9 |
| AirLife | Carefusion | 8 |
| Prochamber Assembly | Respironics Respiratory Drug Delivery (Uk), Ltd. | 6 |
| Threshold | Respironics Respiratory Drug Delivery (Uk), Ltd. | 6 |
| Curaplex | Bound Tree Medical, LLC | 5 |
| Hudson RCI | Medline Industries, Inc. | 5 |
| VersaPAP™ Positive Airway Pressure Device | Trudell Medical International | 4 |
| Curaplex | TRI-Anim Health Services, Inc. | 4 |
| Halyard | Owens & Minor Distribution, Inc. | 4 |
| McKesson | Mckesson Medical-Surgical Inc. | 3 |
Showing 12 of 67. All products under Spirometer, Therapeutic (Incentive)
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | UDI-DI | 2020-12-21 | Class II | Nonconforming Material/Component | Shipping box may contain wrong model. | 4440 | 2024-07-11 |
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.