10MM Flextube B/S With Neonatal Water Traps, Monitoring Line AND 0.5m Limb, 1.6m
Catalogue number 4510000, listed by Intersurgical Ltd., United Kingdom, under Circuit, Breathing (W Connector, Adaptor, Y Piece). 55 manufacturers in China are registered for this product 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 | Intersurgical Ltd., United Kingdom |
|---|---|
| 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-10-15 |
| Record revised | 2025-02-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4510000 | 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 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 |
|---|---|---|---|---|---|
| 2018-04-25 | Class II | Device Design | When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient. | 1340 | 2019-04-09 |
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.