Sentinel Seal
Sentinel Seal Chest Drainage Unit Dry Suction, Easy-Change Connector
30manufacturers in China registered for this device type
6catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Zhejiang (8), Jiangsu (7), Guangdong (7). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Dongguan Junhai Medical Device Co., Ltd. | Dong Guang | Guangdong | Contract manufacturer | 9 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Tianjin Tairuibosi Medical Appliance Co., Ltd. | Tianjin | Tianjin | Private-label distributor | 30 |
Showing 12 of 30. All 30 manufacturers in China registered for Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | GCX |
| Device type | Apparatus, Suction, Operating-Room, Wall Vacuum Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-02-18 |
| Record revised | 2025-12-31 (version 11) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 5 |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8888571562 | In distribution | |
| 8888571513 | In distribution | |
| 8888571489 | In distribution | |
| 8888571562 | Withdrawn | |
| 8888571489 | Withdrawn | |
| 8888571513 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vacutron | Allied Medical LLC | 764 |
| Cardinal Health | Cardinal Health 200, LLC | 310 |
| Aesculap | Aesculap AG | 243 |
| Single Use Professional | Eakin Surgical Ltd | 168 |
| Medi-VAC | Cardinal Health 200, LLC | 158 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 121 |
| Du-O-Vac | W.T. Farley, Inc. | 91 |
| Ambler Surgical | Ambler Surgical, LLC | 66 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Biomet Microfixation | 65 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 44 |
| OMT LLC | OMT, LLC | 39 |
| Argyle | Cardinal Health | 38 |
Showing 12 of 257. All products under Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Recalls
5 of these are 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 |
|---|---|---|---|---|---|
| 2025-12-26 | Class II | Error in labeling | The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may co | 1,169,726 units | |
| 2023-12-21 | Class II | Process control | The above-listed lots of Cardinal Health Medi-Vac CRD” Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister. | 203244 units | |
| 2023-12-21 | Class II | Process control | The above-listed lots of Cardinal Health Medi-Vac CRD” Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister. | 3505730 units | |
| 2023-12-21 | Class II | Process control | The above-listed lots of Cardinal Health Medi-Vac CRD” Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister. | 74515 | |
| 2018-03-28 | Class II | Process control | products may be missing a one-way valve on the fluid patient port. | 3600 units | 2018-11-29 |
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.