Breathing Circuit Set, Dual Limb
Dual limb breathing circuit set with Swivel Y-piece, neonatal flow sensor, neonatal expiratory valve set and pressure line for use with HAMILTON-C1/T1/MR1, 150 cm, neonatal, single-use
33manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
5recalls on this code
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 | Hamilton Medical AG, Switzerland |
|---|---|
| FDA product code | BZO |
| Device type | Set, Tubing And Support, Ventilator (W Harness) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5975 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 260182 | In distribution | |
| 260170 | In distribution | |
| 260180 | In distribution | |
| 260244 | In distribution | |
| 260241 | In distribution | |
| 260169 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 85 |
| Hudson RCI | Teleflex Medical LLC | 82 |
| 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 |
Showing 12 of 356. All products under Set, Tubing And Support, Ventilator (W Harness)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K945740 | 1995-03-23 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2026-05-29 | Class I | Component design/selection | Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in “exhalation obstructed ” alarm, which may result in inadequate ventil | 27,270 pcs | |
| 2025-06-26 | Class I | Process control | Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases | 2,560 | |
| 2015-06-01 | Class II | Device Design | An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement | 154 total – all part numbers | 2015-08-12 |
| 2015-06-01 | Class II | Device Design | An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement | 154 total, all part numbers | 2015-08-12 |
| 2015-06-01 | Class II | Device Design | An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement | 154 total, all part numbers | 2015-08-12 |
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.