Pleur-Evac
Pleur-Evac Adult-Pediatric WET Latex Free International English
88manufacturers in China registered for this device type
58catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (26), Jiangsu (25), Zhejiang (17). 15 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 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Rongxing Plastic Jurong Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 8 |
| Zhejiang Aicor Medical Technology Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 4 |
Showing 12 of 88. All 88 manufacturers in China registered for Bottle, Collection, Vacuum
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | KDQ |
| Device type | Bottle, Collection, Vacuum |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K905768 |
| Record published | 2024-02-07 |
| Record revised | 2025-02-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 6, case of 3, box of 6 |
| Sizes | Total volume 150 to 4350 ml; width 5.5 to 17 in; depth 2.25 to 3.5 in; length 9 to 16.5 in; width 28.575 cm; length 26.67 cm; depth 8.89 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN928757 | Width 6.5 in | In distribution |
| IPN025419 | Length 9 in | In distribution |
| A-8020-08LF | Total Volume 150.0 ml | In distribution |
| IPN028452 | Depth 2.5 in | In distribution |
| IPN927565 | Length 16.5 in | In distribution |
| IPN028484 | Total Volume 2000 ml | In distribution |
| A-7000-08LF | Width 11.0 in | In distribution |
| IPN028482 | Length 9 in | In distribution |
| IPN028446 | Length 16.5 in | In distribution |
| IPN028450 | Length 16.5 in | In distribution |
| IPN010608 | Total Volume 2850 ml | In distribution |
| IPN928750 | Total Volume 2500 ml | In distribution |
| IPN928751 | Width 11 in | In distribution |
| IPN928754 | Length 16.5 in | In distribution |
| IPN028447 | Depth 2.5 in | In distribution |
| IPN010589 | Depth 2.5 in | In distribution |
| A-6000-08LF | Length 15.0 in | In distribution |
| IPN028442 | Total Volume 2100 ml | In distribution |
| IPN928756 | Depth 2.5 in | In distribution |
| IPN929927 | Total Volume 550 ml | In distribution |
| IPN927042 | Total Volume 2000 ml | In distribution |
| IPN010599 | Length 16.5 in | In distribution |
| IPN010586 | Total Volume 2100 ml | In distribution |
| IPN927595 | Total Volume 2000 ml | In distribution |
| IPN928758 | Total Volume 2000 ml | In distribution |
| IPN010606 | Depth 2.5 in | In distribution |
| S-0500 | Depth 2.25 in | In distribution |
| IPN010605 | Depth 2.5 in | In distribution |
| IPN927559 | Depth 2.5 in | In distribution |
| IPN010604 | Depth 2.5 in | In distribution |
| IPN928753 | Length 15 in | In distribution |
| IPN927564 | Depth 2.5 in | In distribution |
| IPN028444 | Depth 2.5 in | In distribution |
| IPN028445 | Total Volume 3500 ml | In distribution |
| IPN028453 | Width 6.5 in | In distribution |
| IPN010600 | Width 16.5 in | In distribution |
| IPN028490 | Width 17 in | In distribution |
| IPN927562 | Length 16.5 in | In distribution |
| IPN010610 | Width 6.5 in | In distribution |
| A-6020-08LF | Length 15.0 in | In distribution |
| S-1100-08LF | Depth 8.89 cm | In distribution |
| IPN010597 | Length 16.5 in | In distribution |
| IPN028451 | Length 16.5 in | In distribution |
| IPN927560 | Length 16.5 in | In distribution |
| IPN927561 | Total Volume 150 ml | In distribution |
| IPN927566 | Total Volume 150 ml | In distribution |
| IPN928749 | Length 15 in | In distribution |
| IPN028443 | Total Volume 1900 ml | In distribution |
| IPN927563 | Total Volume 2850 ml | In distribution |
| IPN010588 | Total Volume 1900 ml | In distribution |
| IPN922041 | Length 9 in | In distribution |
| IPN010590 | Width 16.5 in | In distribution |
| IPN028449 | Depth 2.5 in | In distribution |
| IPN928755 | Length 16.5 in | In distribution |
| IPN025424 | Length 10.5 in | In distribution |
| IPN025430 | Length 10.5 in | In distribution |
| IPN028448 | Length 16.5 in | In distribution |
| A-6002-08LF | Total Volume 1900.0 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 191 |
| Bemis | Bemis Manufacturing Co. | 41 |
| Suction Liner | Shijiazhuang Yuanding Medical Device Co., Ltd. | 40 |
| Medline | Medline Industries, Inc. | 26 |
| Allied Medical LLC | Allied Medical LLC | 25 |
| Suction Liner System | Shijiazhuang Yuanding Medical Device Co., Ltd. | 20 |
| Thora-Vent Thoracic Vent | Uresil, LLC | 16 |
| Medline Industries, Inc. | Medline Industries, Inc. | 15 |
| Bottle, Collection, Vacuum | Carilex Medical, Inc. | 13 |
| Ocean | Atrium Medical Corporation | 13 |
| McKesson | Mckesson Medical-Surgical Inc. | 13 |
| Grownsy | Oak Tech LLC | 11 |
Showing 12 of 216. All products under Bottle, Collection, Vacuum
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2015-03-13 | Class II | Other | Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system. | 2,148 units | 2017-08-14 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2020-06-30 | Class II | Under Investigation by firm | Potential for sterile packaging to be compromised | 204644 each (OUS) | 2026-07-02 |
| 2020-06-30 | Class II | Under Investigation by firm | Potential for sterile packaging to be compromised | 1812 each (US) | 2026-07-02 |
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.