Medline
CATHETER,FOLEY,100%SILICONE,12FR,10ML,LF
17manufacturers in China registered for this device type
72catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | EZL |
| Device type | Catheter, Retention Type, Balloon |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| 510(k) | K082815 |
| Record published | 2016-10-14 |
| Record revised | 2020-12-04 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store product away from direct exposure to light at room temperature |
| Packaging | Pack of 10, pack of 12, case of 12, box of 12 |
| Sizes | Catheter gauge 16 to 18 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYND11500 | In distribution | |
| DYND11786 | In distribution | |
| DYND11780 | In distribution | |
| DYND141018 | In distribution | |
| DYND11502 | In distribution | |
| DYND11756 | In distribution | |
| DYND11554 | In distribution | |
| DYND141020 | In distribution | |
| DYND11762 | In distribution | |
| DYND141014 | In distribution | |
| DYND11574 | In distribution | |
| DYND110508 | In distribution | |
| DYND11800 | In distribution | |
| DYND11918 | Catheter Gauge 18 Fr | In distribution |
| DYND11575 | In distribution | |
| DYND11576 | In distribution | |
| DYND11572 | In distribution | |
| DYND11218 | In distribution | |
| DYND11764 | In distribution | |
| DYND11784 | In distribution | |
| DYND11504 | In distribution | |
| DYND110510 | In distribution | |
| DYND11216 | In distribution | |
| DYND141016 | In distribution | |
| DYND11501 | In distribution | |
| DYND11553 | In distribution | |
| DYND11535 | In distribution | |
| DYND11770 | In distribution | |
| DYND11760 | In distribution | |
| DYND11503 | In distribution | |
| DYND11710 | In distribution | |
| DYND11790 | In distribution | |
| DYND11754 | In distribution | |
| DYND11768 | In distribution | |
| DYND110514 | In distribution | |
| DYND11774 | In distribution | |
| DYND110518 | In distribution | |
| DYND11778 | In distribution | |
| DYND11532 | In distribution | |
| DYND11916 | Catheter Gauge 16 Fr | In distribution |
| DYND11534 | In distribution | |
| DYND110512 | In distribution | |
| DYND11593 | In distribution | |
| DYND11573 | In distribution | |
| DYND11801 | In distribution | |
| DYND11782 | In distribution | |
| DYND11803 | In distribution | |
| DYND11766 | In distribution | |
| DYND141220 | In distribution | |
| DYND11536 | In distribution | |
| DYND11706 | In distribution | |
| DYND11592 | In distribution | |
| DYND11805 | In distribution | |
| DYND11506 | In distribution | |
| DYND141216 | In distribution | |
| DYND11776 | In distribution | |
| DYND11533 | In distribution | |
| DYND11804 | In distribution | |
| DYND11591 | In distribution | |
| DYND11708 | In distribution | |
| DYND11214 | In distribution | |
| DYND110516 | In distribution | |
| DYND11802 | In distribution | |
| DYND11758 | In distribution | |
| DYND11505 | In distribution | |
| DYND141218 | In distribution | |
| DYND11552 | In distribution | |
| DYND11752 | In distribution | |
| DYND11772 | In distribution | |
| DYND11220 | In distribution | |
| DYND11594 | In distribution | |
| DYND11788 | 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 |
| McKesson | Mckesson Medical-Surgical Inc. | 63 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142635 | 2015-01-09 |
| K071423 | 2007-07-18 |
| K052168 | 2006-02-16 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2019-05-28 | Class II | Manufacturing material removal | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | 330 | 2023-01-30 |
| Medline Industries, LP – Northfield | UDI-DI | 2019-05-28 | Class II | Manufacturing material removal | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | 0 | 2023-01-30 |
| Medline Industries, LP – Northfield | UDI-DI | 2019-05-28 | Class II | Manufacturing material removal | Loose silicone particulate was found to be present on the shaft of the silicone catheters. | 0 | 2023-01-30 |
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.