Hudson RCI
ThermaGard Electronically Controlled Nebulizer Heater For Use with HUDSON RCI REF 1770 Variable Concentration Large Volume Nebulizer
42manufacturers in China registered for this device type
220catalogue numbers in this listing
2recalls on this 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | CAF |
| Device type | Nebulizer (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K930525 |
| Record published | 2017-11-22 |
| Record revised | 2025-10-29 (version 17) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Do not freeze symbol |
| Packaging | Case of 50, box of 50, case of 10, case of 20, box of 100, case of 3 |
| Sizes | Length 4 in; height 4.5 in |
| Distribution end date | 2025-10-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN049303 | In distribution | ||
| IPN049678 | In distribution | ||
| IPN044468 | In distribution | ||
| IPN042788 | In distribution | ||
| IPN040637 | In distribution | ||
| IPN040284 | In distribution | ||
| IPN044465 | In distribution | ||
| IPN040616 | In distribution | ||
| IPN044481 | In distribution | ||
| IPN916687 | 100 | In distribution | |
| IPN042770 | In distribution | ||
| IPN040619 | In distribution | ||
| IPN048703 | In distribution | ||
| IPN044479 | In distribution | ||
| IPN042770 | In distribution | ||
| IPN044427 | In distribution | ||
| IPN042948 | In distribution | ||
| IPN049265 | In distribution | ||
| IPN044346 | In distribution | ||
| IPN042747 | In distribution | ||
| IPN916685 | 100 | In distribution | |
| IPN049680 | In distribution | ||
| IPN049250 | In distribution | ||
| IPN044464 | In distribution | ||
| IPN040618 | In distribution | ||
| IPN042692 | In distribution | ||
| IPN049200 | In distribution | ||
| IPN042762 | In distribution | ||
| IPN040617 | In distribution | ||
| IPN044459 | In distribution | ||
| IPN042949 | In distribution | ||
| IPN916690 | 48 | In distribution | |
| IPN049268 | In distribution | ||
| IPN049202 | In distribution | ||
| IPN049126 | In distribution | ||
| IPN042951 | In distribution | ||
| IPN042754 | In distribution | ||
| IPN040621 | In distribution | ||
| IPN049711 | In distribution | ||
| IPN042956 | In distribution | ||
| IPN042948 | In distribution | ||
| IPN914806 | In distribution | ||
| IPN042758 | In distribution | ||
| IPN049706 | In distribution | ||
| IPN044466 | In distribution | ||
| IPN040624 | In distribution | ||
| IPN042943 | In distribution | ||
| IPN049708 | In distribution | ||
| IPN049255 | In distribution | ||
| IPN049709 | In distribution | ||
| IPN040634 | In distribution | ||
| IPN042748 | In distribution | ||
| IPN049677 | In distribution | ||
| IPN048016 | In distribution | ||
| IPN044463 | In distribution | ||
| IPN042755 | In distribution | ||
| IPN043840 | In distribution | ||
| IPN042734 | In distribution | ||
| IPN042945 | In distribution | ||
| IPN043778 | In distribution | ||
| IPN043850 | In distribution | ||
| IPN044347 | In distribution | ||
| IPN043848 | In distribution | ||
| IPN044461 | In distribution | ||
| IPN042753 | In distribution | ||
| IPN042950 | In distribution | ||
| IPN044480 | In distribution | ||
| IPN043844 | In distribution | ||
| IPN044488 | In distribution | ||
| IPN042955 | In distribution | ||
| IPN044311 | In distribution | ||
| IPN042760 | In distribution | ||
| IPN916688 | 100 | In distribution | |
| IPN042749 | In distribution | ||
| IPN044478 | In distribution | ||
| IPN042779 | In distribution | ||
| IPN049196 | In distribution | ||
| IPN040615 | In distribution | ||
| IPN049198 | In distribution | ||
| IPN042756 | In distribution | ||
| IPN044547 | In distribution | ||
| IPN040625 | In distribution | ||
| IPN044490 | In distribution | ||
| IPN916686 | 100 | In distribution | |
| IPN044471 | In distribution | ||
| IPN916689 | 100 | In distribution | |
| IPN043842 | In distribution | ||
| IPN044462 | In distribution | ||
| IPN042757 | In distribution | ||
| IPN042760 | In distribution | ||
| IPN044486 | In distribution | ||
| IPN040280 | In distribution | ||
| IPN042946 | In distribution | ||
| IPN042761 | In distribution | ||
| IPN043838 | In distribution | ||
| IPN043777 | In distribution | ||
| IPN042945 | In distribution | ||
| IPN042759 | In distribution | ||
| IPN044484 | In distribution | ||
| IPN044487 | In distribution | ||
| IPN042945 | In distribution | ||
| IPN049251 | In distribution | ||
| IPN049676 | In distribution | ||
| IPN049247 | In distribution | ||
| IPN049710 | In distribution | ||
| IPN044440 | In distribution | ||
| IPN914467 | Length 4 in | In distribution | |
| IPN042944 | In distribution | ||
| IPN044460 | In distribution | ||
| IPN049194 | In distribution | ||
| IPN044483 | In distribution | ||
| IPN049254 | In distribution | ||
| IPN040620 | In distribution | ||
| IPN044482 | In distribution | ||
| IPN049806 | Withdrawn | ||
| IPN914779 | Withdrawn | ||
| IPN914803 | Withdrawn | ||
| IPN049836 | Withdrawn | ||
| IPN914772 | Withdrawn | ||
| IPN914793 | Withdrawn | ||
| IPN049795 | Withdrawn | ||
| IPN914798 | Withdrawn | ||
| IPN049839 | Withdrawn | ||
| IPN049797 | Withdrawn | ||
| IPN049793 | Withdrawn | ||
| IPN042594 | Withdrawn | ||
| IPN049807 | Withdrawn | ||
| IPN049810 | Withdrawn | ||
| IPN049284 | Withdrawn | ||
| IPN049820 | Withdrawn | ||
| IPN916676 | Withdrawn | ||
| IPN914789 | Withdrawn | ||
| IPN914775 | Withdrawn | ||
| IPN049786 | Withdrawn | ||
| IPN049294 | Withdrawn | ||
| IPN914781 | Withdrawn | ||
| IPN049808 | Withdrawn | ||
| IPN913682 | Withdrawn | ||
| IPN049297 | Withdrawn | ||
| IPN049823 | Withdrawn | ||
| IPN914796 | Withdrawn | ||
| IPN049787 | Withdrawn | ||
| IPN049819 | Withdrawn | ||
| IPN914802 | Withdrawn | ||
| IPN049286 | Withdrawn | ||
| IPN914778 | Withdrawn | ||
| IPN914805 | Withdrawn | ||
| IPN914785 | Withdrawn | ||
| IPN914794 | Withdrawn | ||
| IPN049794 | Withdrawn | ||
| IPN049302 | Withdrawn | ||
| IPN049824 | Withdrawn | ||
| IPN914790 | Withdrawn | ||
| IPN049832 | Withdrawn | ||
| IPN914801 | Withdrawn | ||
| IPN049679 | Withdrawn | ||
| IPN049791 | Withdrawn | ||
| IPN049798 | Withdrawn | ||
| IPN049813 | Withdrawn | ||
| IPN049831 | Withdrawn | ||
| IPN049802 | Withdrawn | ||
| IPN914786 | Withdrawn | ||
| IPN049785 | Withdrawn | ||
| IPN049298 | Withdrawn | ||
| IPN914791 | Withdrawn | ||
| IPN914792 | Withdrawn | ||
| IPN049792 | Withdrawn | ||
| IPN914795 | Withdrawn | ||
| IPN914799 | Withdrawn | ||
| IPN049293 | Withdrawn | ||
| IPN049295 | Withdrawn | ||
| IPN914777 | Withdrawn | ||
| IPN049796 | Withdrawn | ||
| IPN049803 | Withdrawn | ||
| IPN049305 | Withdrawn | ||
| IPN049306 | Withdrawn | ||
| IPN049790 | Withdrawn | ||
| IPN049304 | Withdrawn | ||
| IPN914808 | Withdrawn | ||
| IPN049822 | Withdrawn | ||
| IPN914773 | Withdrawn | ||
| IPN914787 | Withdrawn | ||
| IPN049830 | Withdrawn | ||
| IPN049292 | Withdrawn | ||
| IPN914776 | Withdrawn | ||
| IPN049838 | Withdrawn | ||
| IPN044489 | Withdrawn | ||
| IPN914784 | Withdrawn | ||
| IPN049829 | Withdrawn | ||
| IPN914780 | Withdrawn | ||
| IPN049299 | Withdrawn | ||
| IPN049801 | Withdrawn | ||
| IPN049811 | Withdrawn | ||
| IPN049296 | Withdrawn | ||
| IPN913959 | Withdrawn | ||
| IPN049828 | Withdrawn | ||
| IPN916677 | Withdrawn | ||
| IPN049804 | Withdrawn | ||
| IPN914040 | Withdrawn | ||
| IPN049291 | Withdrawn | ||
| IPN049301 | Withdrawn | ||
| IPN049707 | Withdrawn | ||
| IPN916678 | Withdrawn | ||
| IPN914774 | Withdrawn | ||
| IPN049834 | Withdrawn | ||
| IPN049789 | Withdrawn | ||
| IPN049800 | Withdrawn | ||
| IPN049805 | Withdrawn | ||
| IPN914782 | Withdrawn | ||
| IPN049833 | Withdrawn | ||
| IPN049809 | Withdrawn | ||
| IPN914804 | Withdrawn | ||
| IPN914797 | Withdrawn | ||
| IPN049812 | Withdrawn | ||
| IPN049788 | Withdrawn | ||
| IPN914807 | Withdrawn | ||
| IPN914788 | Withdrawn | ||
| IPN914809 | Withdrawn | ||
| IPN049825 | Withdrawn | ||
| IPN049300 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Medline | Medline Industries, Inc. | 38 |
Showing 12 of 541. All products under Nebulizer (Direct Patient Interface)
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2023-08-04 | Class I | Process control | Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers. | 18,000 units | |
| Teleflex Medical LLC | 510(k) number | 2007-08-22 | Not classified | Release of Material/Component prior to receiving test results | Decreased in flow output; through the nebulizer -(when used at higher oxygen concentration settings, this decrease in flow, may lower the oxygen concentration inspired by the patient) | 215,656 units | 2012-08-13 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-09-03 | Class II | Packaging change control | Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor. | 3,193,548 ea | 2017-08-14 |
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.