McKesson
Catheter, Foley Straight TIP Silicone Coated Latex 16" 24FR 15-30CC
17manufacturers in China registered for this device type
63catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (4), Guangdong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Haiyan Kangyuan Medical Instrument Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 17 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Well Lead Medical (Hainan) Co., Ltd. | Haikou | Hainan | Contract manufacturer | 3 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
Showing 12 of 17. All 17 manufacturers in China registered for Catheter, Retention Type, Balloon
Record
| Listed by | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | EZL |
| Device type | Catheter, Retention Type, Balloon |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| 510(k) | K091699 |
| Record published | 2019-12-12 |
| Record revised | 2020-12-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16-LFOL522C | In distribution | |
| 16-SLFOL3024 | In distribution | |
| 16-SLFOL522 | In distribution | |
| 16-LFOL524 | In distribution | |
| 16-LFOL518C | In distribution | |
| 16-LFOL3014 | In distribution | |
| 16-LFOL3016 | In distribution | |
| 16-LFOL516C | In distribution | |
| 16-SLFOL3018 | In distribution | |
| 16-LFOL520 | In distribution | |
| 16-SLFOL3012 | In distribution | |
| 16-LFOL522 | In distribution | |
| 16-SLFOL524 | In distribution | |
| 16-LFOL3016C | In distribution | |
| 16-SFOL516 | In distribution | |
| 16-SFOL3020C | In distribution | |
| 16-SFOL512 | In distribution | |
| 16-SFOL520 | In distribution | |
| 16-LFOL524C | In distribution | |
| 16-SFOL524 | In distribution | |
| 16-LFOL3024C | In distribution | |
| 16-SFOL3024C | In distribution | |
| 16-LFOL3024 | In distribution | |
| 16-SLFOL3022 | In distribution | |
| 16-LFOL520C | In distribution | |
| 16-LFOL514 | In distribution | |
| 16-SFOL512C | In distribution | |
| 16-SFOL3022 | In distribution | |
| 16-SFOL518 | In distribution | |
| 16-LFOL3018C | In distribution | |
| 16-SFOL514C | In distribution | |
| 16-SLFOL3020 | In distribution | |
| 16-LFOL512 | In distribution | |
| 16-SLFOL3016 | In distribution | |
| 16-LFOL518 | In distribution | |
| 16-SFOL3022C | In distribution | |
| 16-LFOL516 | In distribution | |
| 16-SFOL516C | In distribution | |
| 16-LFOL3018 | In distribution | |
| 16-SFOL3018C | In distribution | |
| 16-SFOL522C | In distribution | |
| 16-LFOL3020 | In distribution | |
| 16-LFOL3022 | In distribution | |
| 16-SFOL3020 | In distribution | |
| 16-SLFOL516 | In distribution | |
| 16-SFOL522 | In distribution | |
| 16-LFOL514C | In distribution | |
| 16-SLFOL3014 | In distribution | |
| 16-LFOL512C | In distribution | |
| 16-SFOL3014 | In distribution | |
| 16-SLFOL514 | In distribution | |
| 16-LFOL3022C | In distribution | |
| 16-SLFOL518 | In distribution | |
| 16-SFOL524C | In distribution | |
| 16-SFOL3018 | In distribution | |
| 16-SFOL3016 | In distribution | |
| 16-LFOL3020C | In distribution | |
| 16-SFOL3024 | In distribution | |
| 16-SLFOL512 | In distribution | |
| 16-SFOL520C | In distribution | |
| 16-SLFOL520 | In distribution | |
| 16-SFOL518C | In distribution | |
| 16-SFOL514 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| All Silicone Foley Catheter | Well Lead Medical Co., Ltd. | 175 |
| Dover | Cardinal Health 200, LLC | 85 |
| Dover | Cardinal Health | 82 |
| Rusch | Teleflex Medical LLC | 79 |
| Porges Coloplast | Coloplast A/S | 74 |
| Medline | Medline Industries, Inc. | 72 |
| TruCath | HR Pharmaceuticals Inc. | 59 |
| Folysil | Coloplast A/S | 47 |
| Sunmed | SunMed Group Holdings, LLC | 35 |
| Universa | Cook Incorporated | 31 |
| AMSure ® Hydrophilic Latex Foley Catheters | Amsino Medical Inc. | 31 |
| AMSure® Silicone Coated Latex Foley Catheter | Amsino Medical Inc. | 28 |
Showing 12 of 135. All products under Catheter, Retention Type, Balloon
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.