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Pack, Sensormedics 3100A/B Filtered Circuit Disposable Adptrs Cnvc BCG, CE 2797
33manufacturers in China registered for this device type
37catalogue 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 | Mallinckrodt Manufacturing 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 | Contract manufacturer, Remanufacturer, Manufacturer |
| 510(k) | K131686 |
| Record published | 2023-05-10 |
| Record revised | 2023-07-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 15 to 95 % RH; Storage environment atmospheric pressure 57 to 110 KiloPascal |
| Packaging | Pack of 5, pack of 5 of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 81124 | In distribution | |
| 91353 | In distribution | |
| 50403 | In distribution | |
| 81094 | In distribution | |
| 50402 | In distribution | |
| 50415 | In distribution | |
| 81087 | In distribution | |
| 81090 | In distribution | |
| 91424 | In distribution | |
| 81098 | In distribution | |
| 81092 | In distribution | |
| 91425 | In distribution | |
| 81091 | In distribution | |
| 81124 | In distribution | |
| 91352 | In distribution | |
| 81088 | In distribution | |
| 81125 | In distribution | |
| 10014 | In distribution | |
| 91344 | In distribution | |
| 81095 | In distribution | |
| 91345 | In distribution | |
| 50428 | In distribution | |
| 91349 | In distribution | |
| 91346 | In distribution | |
| 91343 | In distribution | |
| 50387 | In distribution | |
| 81096 | In distribution | |
| 50383 | In distribution | |
| 81086 | In distribution | |
| 81097 | In distribution | |
| 50417 | In distribution | |
| 81126 | In distribution | |
| 91348 | In distribution | |
| 91347 | In distribution | |
| 91426 | In distribution | |
| 81093 | In distribution | |
| 91350 | 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 |
| 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 UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mallinckrodt Manufacturing LLC | UDI-DI | 2023-08-08 | Class I | Under Investigation by firm | The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. | 13,602 units |
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.