Mallinckrodt
Endobronchial Suction Catheters with Color Coded Connectors; Endobronchial Tube; Endobronchial Tube Accessories,Right with CPAP,(2) Right Angle Swivel Connectors; Carlens Y Adapter
9manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Fujian (3), elsewhere (1). 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 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| 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 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Shenzhen Wellcore Well Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | BYE |
| Device type | Attachment, Breathing, Positive End Expiratory Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5965 |
| 510(k) | K912240 |
| Record published | 2015-08-28 |
| Record revised | 2026-04-07 (version 12) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not expose to UV |
| Packaging | Case of 10, pack_or_inner_pack of 5 |
| Sizes | Catheter gauge 28 to 41 Fr |
| Distribution end date | 2025-06-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 126137 | French Catheter Gauge,10,French;French Catheter Gauge,37,French; | In distribution |
| 126135 | French Catheter Gauge,10,French;French Catheter Gauge,35,French; | In distribution |
| 125135 | French Catheter Gauge,10,French;French Catheter Gauge,35,French; | In distribution |
| 126141 | French Catheter Gauge,12,French;French Catheter Gauge,41,French; | In distribution |
| 125128 | Catheter Gauge 28 Fr | In distribution |
| 125137 | Catheter Gauge 37 Fr | In distribution |
| 126139 | French Catheter Gauge,10,French;French Catheter Gauge,39,French; | In distribution |
| 125141 | Catheter Gauge 41 Fr | In distribution |
| 125139 | French Catheter Gauge,10,French;French Catheter Gauge,39,French; | In distribution |
| 125132 | French Catheter Gauge,8,French;French Catheter Gauge,32,French; | In distribution |
| 85006 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O2-MAX | Pulmodyne Inc. | 136 |
| 02-MAX | Pulmodyne Inc. | 83 |
| 02-RESQ | Pulmodyne Inc. | 43 |
| Flow-Safe II Disposable CPAP System | Mercury Medical Enterprises, LLC | 36 |
| Curaplex® | Bound Tree Medical, LLC | 31 |
| AincA | Anesthesia Associates, Inc. | 30 |
| Flow-Safe Disposable CPAP System | Mercury Medical Enterprises, LLC | 29 |
| Attachment, Breathing, Positive End Expiratory Pressure | Galemed Corp. | 25 |
| Shiley | Covidien LP | 21 |
| Infant Resuscitation Kit. T-Piece Circuit | Flexicare Medical Ltd. | 20 |
| AirLife | Carefusion | 17 |
| O2-RESQ | Pulmodyne Inc. | 17 |
Showing 12 of 139. All products under Attachment, Breathing, Positive End Expiratory Pressure
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.