Rusch
Bain Breathing Circuit, Adult, 60'', 3L Latex Bag, and Gas Sampling Elbow
55manufacturers in China registered for this device type
46catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (18), Guangdong (18), Jiangsu (5). 18 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 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| 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 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Hangzhou Formed Medical Devices Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
Showing 12 of 55. All 55 manufacturers in China registered for Circuit, Breathing (W Connector, Adaptor, Y Piece)
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | CAI |
| Device type | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5240 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2022-10-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, box of 20, box of 75, case of 10, box of 12, box of 18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN044043 | In distribution | |
| IPN929067 | In distribution | |
| IPN924597 | In distribution | |
| IPN913361 | In distribution | |
| IPN913362 | In distribution | |
| IPN924698 | In distribution | |
| IPN924610 | In distribution | |
| IPN924599 | In distribution | |
| IPN924607 | In distribution | |
| IPN924595 | In distribution | |
| IPN924577 | In distribution | |
| IPN924594 | In distribution | |
| IPN043984 | In distribution | |
| IPN913359 | In distribution | |
| IPN044044 | In distribution | |
| IPN924614 | In distribution | |
| IPN044046 | In distribution | |
| IPN044045 | In distribution | |
| IPN924598 | In distribution | |
| IPN924696 | In distribution | |
| IPN913363 | In distribution | |
| IPN924685 | In distribution | |
| IPN913353 | In distribution | |
| IPN924601 | In distribution | |
| IPN924681 | In distribution | |
| IPN924603 | In distribution | |
| IPN924608 | In distribution | |
| IPN913356 | In distribution | |
| IPN924609 | In distribution | |
| IPN924613 | In distribution | |
| IPN044047 | In distribution | |
| IPN924606 | In distribution | |
| IPN924697 | In distribution | |
| IPN924596 | In distribution | |
| IPN913347 | In distribution | |
| IPN924682 | In distribution | |
| IPN924600 | In distribution | |
| IPN044048 | In distribution | |
| IPN924605 | In distribution | |
| IPN924618 | In distribution | |
| IPN913355 | In distribution | |
| IPN924602 | In distribution | |
| IPN044050 | In distribution | |
| IPN924604 | In distribution | |
| IPN044049 | In distribution | |
| IPN913354 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 3,457 |
| Vital Signs™ | Airlife, Inc. | 1,018 |
| Hudson RCI | Teleflex Medical LLC | 176 |
| Vital Signs™ | AirLife Finland Oy | 143 |
| Universal F2®ANESTHESIA Breathing Circuit | King Systems Corporation. | 133 |
| Universal FLEX2®BREATHING Circuit | King Systems Corporation. | 123 |
| Adult Ultra Flex®anesthesia Breathing Circuit | King Systems Corporation. | 111 |
| Portex | ICU Medical, Inc | 95 |
| AincA® | Anesthesia Associates, Inc. | 76 |
| Medline/MMS Sales | Medline Industries, Inc. | 73 |
| Pediatric Ultra Flex®anesthesia Breathing Circuit | King Systems Corporation. | 71 |
| Vital Signs™ | Vyaire Medical, Inc. | 70 |
Showing 12 of 522. All products under Circuit, Breathing (W Connector, Adaptor, Y Piece)
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2014-09-08 | Class I | Device Design | The pediatric breathing circuits can crack prior to and during use. | 27,176 units | 2016-08-16 |
| 2014-07-09 | Class II | Nonconforming Material/Component | The temperature probe does not properly connect to the temperature port. | 11,679 units | 2017-03-09 |
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.