Pleur-Evac
Pleur Evac Connector 5 Millimeter X 10 Millimeter Straight
15manufacturers in China registered for this device type
26catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (3), Zhejiang (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
| Shaoxing Undis Medical Technology Company Limited | Shaoxing | Zhejiang | Manufacturer | 17 |
Showing 12 of 15. All 15 manufacturers in China registered for Connector, Catheter
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GCD |
| Device type | Connector, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-05-08 |
| Record revised | 2022-01-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 20 |
| Sizes | Length 2 to 3.5 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN029227 | Length 2 in | In distribution |
| IPN028480 | Length 3.5 in | In distribution |
| IPN929929 | Length 3.5 in | In distribution |
| IPN916510 | Length 2 in | In distribution |
| IPN028478 | Length 3.5 in | In distribution |
| PE103 | Length 3.5 in | In distribution |
| IPN929931 | Length 3.5 in | In distribution |
| IPN028435 | Length 2 in | In distribution |
| IPN023858 | Length 3.5 in | In distribution |
| IPN028477 | Length 3.5 in | In distribution |
| IPN023861 | Length 2 in | In distribution |
| PE100 | Length 3.5 in | In distribution |
| IPN023857 | Length 3.5 in | In distribution |
| IPN929930 | Length 3.5 in | In distribution |
| PE101 | Length 3.5 in | In distribution |
| IPN023860 | Length 3.5 in | In distribution |
| PE104-08 | Length 2.0 in | In distribution |
| IPN028481 | Length 2 in | In distribution |
| PE105 | Length 2.0 in | In distribution |
| IPN929357 | Length 2.0 in | In distribution |
| IPN927557 | Length 2 in | In distribution |
| IPN023859 | Length 3.5 in | In distribution |
| IPN028479 | Length 3.5 in | In distribution |
| IPN929932 | Length 3.5 in | In distribution |
| IPN023862 | Length 2 in | In distribution |
| PE102 | Length 3.5 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Silicone Penrose Drain Tube | Fortune Medical Instrument Corp. | 38 |
| Silicone Flat Drain | Fortune Medical Instrument Corp. | 14 |
| Silicone Round Drain | Fortune Medical Instrument Corp. | 14 |
| Cook | Cook Incorporated | 14 |
| Silicone Round Drain Kit | Fortune Medical Instrument Corp. | 12 |
| Argyle | Cardinal Health | 10 |
| Cardinal Health | Cardinal Health 200, LLC | 9 |
| Silicone Flat Drain Kit | Fortune Medical Instrument Corp. | 8 |
| Argyle | Cardinal Health 200, LLC | 8 |
| Silicone Endo-Drain Kit | Fortune Medical Instrument Corp. | 6 |
| Silicone Vac-Drain | Fortune Medical Instrument Corp. | 6 |
| Silicone Vac-Drain Kit | Fortune Medical Instrument Corp. | 6 |
Showing 12 of 49. All products under Connector, Catheter
Recalls
4 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 |
|---|---|---|---|---|---|
| 2017-04-21 | Class II | Labeling False and Misleading | Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used. | 19,043 units in total | 2020-01-27 |
| 2017-04-21 | Class II | Labeling False and Misleading | Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used. | 19,043 units in total | 2020-01-27 |
| 2017-04-21 | Class II | Labeling False and Misleading | 19,043 units in total | 2020-01-27 | |
| 2017-04-21 | Class II | Labeling False and Misleading | Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used. | 19,043 units in total | 2020-01-27 |
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.