Hudson RCI
Infant Nasal Cpap Cannula, SZ 3,INTL
18manufacturers in China registered for this device type
69catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (2), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Suzhou Avon Textile Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Hunan Beyond Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 3 |
| Shanghai Baron Technologies Co Ltd | Shanghai | Shanghai | Contract manufacturer | 3 |
| BMC(Dongguan) Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Zhejiang Baron Technologies Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Resvent Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Showing 12 of 18. All 18 manufacturers in China registered for Ventilator, Non-Continuous (Respirator)
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K871157 |
| Record published | 2019-07-17 |
| Record revised | 2022-03-22 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, case of 10, box of 50 |
| Distribution end date | 2025-10-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN913764 | In distribution | |
| IPN042718 | In distribution | |
| IPN913706 | In distribution | |
| IPN044448 | In distribution | |
| IPN042730 | In distribution | |
| IPN913769 | In distribution | |
| IPN044449 | In distribution | |
| IPN042719 | In distribution | |
| IPN913770 | In distribution | |
| IPN044457 | In distribution | |
| IPN913708 | In distribution | |
| IPN042723 | In distribution | |
| IPN913773 | In distribution | |
| IPN913707 | In distribution | |
| IPN042724 | In distribution | |
| IPN042729 | In distribution | |
| IPN913701 | In distribution | |
| IPN913771 | In distribution | |
| IPN913700 | In distribution | |
| IPN044451 | In distribution | |
| IPN042728 | In distribution | |
| IPN913772 | In distribution | |
| IPN044453 | In distribution | |
| IPN913703 | In distribution | |
| IPN913710 | In distribution | |
| IPN042726 | In distribution | |
| IPN044452 | In distribution | |
| IPN913766 | In distribution | |
| IPN913765 | In distribution | |
| IPN913768 | In distribution | |
| IPN042727 | In distribution | |
| IPN044450 | In distribution | |
| IPN913709 | In distribution | |
| IPN044456 | In distribution | |
| IPN913775 | In distribution | |
| IPN042722 | In distribution | |
| IPN913767 | In distribution | |
| IPN042725 | In distribution | |
| IPN044447 | In distribution | |
| IPN044455 | In distribution | |
| IPN913705 | In distribution | |
| IPN042720 | In distribution | |
| IPN044454 | In distribution | |
| IPN913699 | In distribution | |
| IPN042721 | In distribution | |
| IPN913704 | In distribution | |
| IPN044458 | In distribution | |
| IPN913703 | Withdrawn | |
| IPN913699 | Withdrawn | |
| IPN913700 | Withdrawn | |
| IPN913766 | Withdrawn | |
| IPN913706 | Withdrawn | |
| IPN913769 | Withdrawn | |
| IPN913773 | Withdrawn | |
| IPN913768 | Withdrawn | |
| IPN913772 | Withdrawn | |
| IPN913705 | Withdrawn | |
| IPN913767 | Withdrawn | |
| IPN913710 | Withdrawn | |
| IPN913704 | Withdrawn | |
| IPN913701 | Withdrawn | |
| IPN913708 | Withdrawn | |
| IPN913709 | Withdrawn | |
| IPN913771 | Withdrawn | |
| IPN913775 | Withdrawn | |
| IPN913765 | Withdrawn | |
| IPN913770 | Withdrawn | |
| IPN913764 | Withdrawn | |
| IPN913707 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DreamStation | Respironics Inc. | 386 |
| DreamWear | Respironics Inc. | 183 |
| REMstar System One 60 Series | Respironics Inc. | 163 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 152 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 136 |
| Ventilator, Non-Continuous (Respirator) | Hans Rudolph, Inc. | 115 |
| BiPAP System One 60 Series | Respironics Inc. | 105 |
| Ventilator, Non-Continuous (Respirator) | Salter Labs | 85 |
| BiTrac Select | Pulmodyne Inc. | 79 |
| Yuwell Sleep Apnea Breathing Therapy Mask | Suzhou Yuyue Medical Technology Co., Ltd. | 76 |
| AF541 | Respironics Inc. | 71 |
| CPAP Masks | Sunset Healthcare Solutions, Inc. | 69 |
Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2007-03-23 | Not classified | Other | The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator’s ability to detect an accurate pressure reading. | 13,530 for all products | 2009-11-16 |
| Teleflex Medical LLC | 510(k) number | 2007-03-23 | Not classified | Other | The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator’s ability to detect an accurate pressure reading. | 13,530 for all products | 2009-11-16 |
| Teleflex Medical LLC | 510(k) number | 2007-03-23 | Not classified | Other | The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator’s ability to detect an accurate pressure reading. | 13,530 for all products | 2009-11-16 |
| Teleflex Medical LLC | 510(k) number | 2007-03-23 | Not classified | Other | The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator’s ability to detect an accurate pressure reading. | 13,530 for all products | 2009-11-16 |
| Teleflex Medical LLC | 510(k) number | 2007-03-23 | Not classified | Other | The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator’s ability to detect an accurate pressure reading. | 13,530 for all products | 2009-11-16 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-06-14 | Class I | Device Design | Device vented gas below the stated pressure. | 9,312 each | 2024-06-12 |
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.