Rocket
Rocket IPC Drainage Line with Wide Bore Connector
3manufacturers in China registered for this device type
3catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
Record
| Listed by | Rocket Medical PLC, United Kingdom |
|---|---|
| FDA product code | DWM |
| Device type | Apparatus, Suction, Patient Care |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5050 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K123033 |
| Record published | 2019-06-18 |
| Record revised | 2025-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -5 to 30 °C; Storage environment humidity 1 to 70 % RH; Handling environment humidity 1 to 70 % RH; Handling environment atmospheric pressure 101 to 101 KiloPascal; Handling environment temperature -5 to 40 °C; Storage environment atmospheric pressure 101 to 101 KiloPascal |
| Packaging | Box of 5, inner carton of 5, outer carton of 2, inner carton of 10, outer carton of 28 |
| Sizes | Total volume 1000 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R51411-00-00 | Total Volume 1000.0 ml | In distribution |
| R54400-00-00 | In distribution | |
| R54410-WB-DL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aspira® | Merit Medical Systems, Inc. | 20 |
| PleurX | Carefusion 2200, Inc. | 14 |
| Asept | B. Braun Interventional Systems, Inc. | 5 |
| Apparatus, Suction, Patient Care | Carefusion 2200, Inc. | 3 |
| Aspira Drainage Tray | Bard Access Systems, Inc. | 3 |
| Asept Pleural Drainage System | PFM Medical, Inc | 2 |
| Passio Redressing Kit | Bearpac Medical, LLC | 2 |
| Passio Handheld Control Unit | Bearpac Medical, LLC | 1 |
| Passio Disposable Collection System | Bearpac Medical, LLC | 1 |
| Passio Adapter Kit | Bearpac Medical, LLC | 1 |
| Aspira Drainage Kit | Bard Access Systems, Inc. | 1 |
| Passio Valve Cap Kit | Bearpac Medical, LLC | 1 |
Showing 12 of 17. All products under Apparatus, Suction, Patient Care
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210509 | 2021-09-09 |
| K163321 | 2017-08-17 |
| K123033 | 2013-02-01 |
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.