Hudson RCI
Universal Neonatal Ventilator Circuit Single Heated Limb with 12- inch Remote Temperature Port (21-volt)
33manufacturers in China registered for this device type
82catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (14), Zhejiang (8), Jiangsu (3). 7 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 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Dongguan Plastiflex Hose Technology Ltd | Dongguan | Guangdong | Contract manufacturer | 3 |
| Worldcross Industries Co., Ltd. | Dong Yang | Zhejiang | Contract manufacturer | 3 |
| BMC(Dongguan) Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Guangzhou Schauenburg-Truplast Hose Technology Ltd. | Guangzhou | Guangdong | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Tiger Medical Group | Shanghai | Shanghai | Specification developer | 38 |
| Hangzhou Weize IMP & EXP Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 34 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Evereast Medical Products Group Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
Showing 12 of 33. All 33 manufacturers in China registered for Set, Tubing And Support, Ventilator (W Harness)
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | BZO |
| Device type | Set, Tubing And Support, Ventilator (W Harness) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5975 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K903083 |
| Record published | 2019-05-09 |
| Record revised | 2022-11-28 (version 6) |
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 |
| Storage | Special storage condition: Store in cool, dry place |
| Packaging | Case of 50, case of 20, case of 10, case of 5, box of 25, case of 100 |
| Distribution end date | 2025-10-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN913784 | In distribution | ||
| IPN913335 | In distribution | ||
| IPN045200 | In distribution | ||
| IPN042372 | In distribution | ||
| IPN042467 | In distribution | ||
| IPN045212 | In distribution | ||
| IPN045187 | In distribution | ||
| IPN042548 | In distribution | ||
| IPN042234 | In distribution | ||
| IPN042373 | In distribution | ||
| IPN913718 | 10 | In distribution | |
| IPN042547 | In distribution | ||
| IPN042546 | In distribution | ||
| IPN913801 | In distribution | ||
| IPN049887 | In distribution | ||
| IPN044040 | In distribution | ||
| IPN045183 | In distribution | ||
| IPN042233 | In distribution | ||
| IPN042448 | 10 | In distribution | |
| IPN042375 | In distribution | ||
| IPN045184 | In distribution | ||
| IPN044020 | In distribution | ||
| IPN045203 | In distribution | ||
| IPN042804 | 10 | In distribution | |
| IPN044024 | In distribution | ||
| IPN049888 | In distribution | ||
| IPN042460 | In distribution | ||
| IPN042215 | In distribution | ||
| IPN044039 | In distribution | ||
| IPN044038 | In distribution | ||
| IPN049885 | In distribution | ||
| IPN043837 | In distribution | ||
| IPN045182 | In distribution | ||
| IPN044023 | In distribution | ||
| IPN045211 | In distribution | ||
| IPN042371 | In distribution | ||
| IPN042932 | In distribution | ||
| IPN913717 | 100 | In distribution | |
| IPN049889 | In distribution | ||
| IPN042717 | In distribution | ||
| IPN042465 | In distribution | ||
| IPN042593 | 50 | In distribution | |
| IPN045189 | In distribution | ||
| IPN042372 | In distribution | ||
| IPN045186 | In distribution | ||
| IPN044018 | In distribution | ||
| IPN044019 | In distribution | ||
| IPN042459 | In distribution | ||
| IPN042466 | In distribution | ||
| IPN042803 | 100 | In distribution | |
| IPN049999 | In distribution | ||
| IPN913787 | In distribution | ||
| IPN045201 | In distribution | ||
| IPN042549 | In distribution | ||
| IPN045180 | In distribution | ||
| IPN049886 | In distribution | ||
| IPN044426 | In distribution | ||
| IPN042374 | In distribution | ||
| IPN049863 | In distribution | ||
| IPN913812 | In distribution | ||
| IPN913334 | In distribution | ||
| IPN042231 | In distribution | ||
| IPN049773 | 10 | Withdrawn | |
| IPN926247 | Withdrawn | ||
| IPN045196 | Withdrawn | ||
| IPN045198 | Withdrawn | ||
| IPN913798 | Withdrawn | ||
| IPN049777 | Withdrawn | ||
| IPN913925 | 50 | Withdrawn | |
| IPN045191 | Withdrawn | ||
| IPN049818 | Withdrawn | ||
| IPN042518 | 10 | Withdrawn | |
| IPN049774 | Withdrawn | ||
| IPN049778 | Withdrawn | ||
| IPN049779 | 10 | Withdrawn | |
| IPN913797 | Withdrawn | ||
| IPN045197 | Withdrawn | ||
| IPN049784 | Withdrawn | ||
| IPN913799 | Withdrawn | ||
| IPN913788 | Withdrawn | ||
| IPN913813 | Withdrawn | ||
| IPN049814 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 85 |
| Classic RT | Plastiflex Group NV | 63 |
| INOmax | Mallinckrodt Manufacturing LLC | 37 |
| AirLife™ | Airlife, Inc. | 26 |
| Vadi Medical | Vadi Medical Technology Co., Ltd. | 17 |
| Ventilator Circuit | King Systems Corporation. | 16 |
| Wellead Oxygen Tubing | Well Lead Medical Co., Ltd. | 15 |
| Gas Sampling Line | Westmed, Inc. | 15 |
| Breathing circuit set, coaxial | Hamilton Medical AG | 14 |
| Create Biotech | Create Biotech Co., Ltd. | 13 |
| CPAP Tubing | Exceleron Medical, LLC | 10 |
| Set, Tubing And Support, Ventilator (W Harness) | Galemed Corp. | 10 |
Showing 12 of 356. All products under Set, Tubing And Support, Ventilator (W Harness)
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2026-07-13 | Class II | Under Investigation by firm | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. D | 145525 units |
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 |
|---|---|---|---|---|
| 2022-04-11 | Class II | Device Design | Reports received of torn corrugated breathing tubes. | 290,809 eaches |
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.