Medline
Tray,foley,erase CAUTI,100%SILI,16FR10ML
12manufacturers in China registered for this device type
267catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (4), Shanghai (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Shaoxing Fuqing Health Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OHR |
| Device type | Catheter Care Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Premarket notification | Exempt |
| Record published | 2022-11-30 |
| Record revised | 2020-12-04 (version 8) |
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 at room temperature. |
| Packaging | Case of 10, pack of 10, pack of 20, case of 20 |
| Sizes | Catheter gauge 6 to 18 Fr; total volume 10 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| URO170216C | In distribution | |
| DYND160716 | In distribution | |
| UROT1096 | Catheter Gauge 14 Fr | In distribution |
| DYND11NS12S | In distribution | |
| UROT1005 | In distribution | |
| URO170816CN | In distribution | |
| DYND12110 | In distribution | |
| UROT1048 | Catheter Gauge 16 Fr | In distribution |
| URO175814T | In distribution | |
| URO180816TS | In distribution | |
| URO170418 | In distribution | |
| URO170814TSQ | In distribution | |
| URO180116 | Catheter Gauge 16 Fr | In distribution |
| URO1SPLUM18 | In distribution | |
| UROT1061 | Catheter Gauge 18 Fr | In distribution |
| URO170810T | Catheter Gauge 10 Fr | In distribution |
| URO170214C | Catheter Gauge 14 Fr | In distribution |
| URO170350 | In distribution | |
| UROT1101 | Catheter Gauge 14 Fr | In distribution |
| DYND1518SEC | In distribution | |
| DYND160114 | In distribution | |
| URO170812TS | Catheter Gauge 12 Fr | In distribution |
| DYND11524 | In distribution | |
| URO170812S | Catheter Gauge 12 Fr | In distribution |
| DYND160816T | In distribution | |
| DYND160816 | In distribution | |
| URO175816T | In distribution | |
| URO4MP16 | In distribution | |
| URO180814TS | In distribution | |
| URO180814S | Total Volume 10 ml | In distribution |
| UROT1026 | Catheter Gauge 18 Fr | In distribution |
| URO170516S | In distribution | |
| URO170518SQ | In distribution | |
| DYND1516SEC | In distribution | |
| DYND160816S | In distribution | |
| URO170818 | In distribution | |
| URO170350A | In distribution | |
| URO170416Q | In distribution | |
| UROT1116 | In distribution | |
| URO180816C | Catheter Gauge 16 Fr | In distribution |
| URO180200 | In distribution | |
| URO180716CN | Catheter Gauge 16 Fr | In distribution |
| DYND160218S | In distribution | |
| DYND160414 | In distribution | |
| DYND160808 | In distribution | |
| UROT1123 | In distribution | |
| URO170518 | In distribution | |
| UROT1125 | In distribution | |
| URO170200Q | In distribution | |
| DYND160818T | In distribution | |
| URO170714 | In distribution | |
| URO1SPLDB18 | Catheter Gauge 18 Fr | In distribution |
| UROT1058 | Catheter Gauge 16 Fr | In distribution |
| UROT1029B | Catheter Gauge 16 Fr | In distribution |
| URO170916P | Catheter Gauge 16 Fr | In distribution |
| DYND160514 | In distribution | |
| URO170416 | In distribution | |
| URO170200 | In distribution | |
| URO170814S | In distribution | |
| URO170816CS | Catheter Gauge 16 Fr | In distribution |
| URO170516SQ | In distribution | |
| URO170214 | In distribution | |
| URO170814T | In distribution | |
| DYNDT1006A | Catheter Gauge 12 Fr | In distribution |
| URO180714 | Catheter Gauge 14 Fr | In distribution |
| DYND140418 | Catheter Gauge 18 Fr | In distribution |
| DYND160718 | In distribution | |
| UROT1100 | Catheter Gauge 14 Fr | In distribution |
| URO1SPLUM14 | In distribution | |
| UROT1030B | Catheter Gauge 16 Fr | In distribution |
| UROT1033 | In distribution | |
| URO170718 | In distribution | |
| DYND1516SIL | In distribution | |
| DYND18350 | Catheter Gauge 15 Fr | In distribution |
| UROT1126 | In distribution | |
| UROT1055 | Catheter Gauge 14 Fr | In distribution |
| DYND18100 | Total Volume 10 ml | In distribution |
| URO180814 | Catheter Gauge 14 Fr | In distribution |
| URO170812 | In distribution | |
| URO180814CN | Catheter Gauge 14 Fr | In distribution |
| UROT1036 | Catheter Gauge 18 Fr | In distribution |
| DYND10350 | Catheter Gauge 15 Fr | In distribution |
| DYND10300 | In distribution | |
| URO180810S | Catheter Gauge 10 Fr | In distribution |
| DYND160812T | In distribution | |
| URO180816 | Catheter Gauge 16 Fr | In distribution |
| URO170816TS | In distribution | |
| URO180814T | Catheter Gauge 14 Fr | In distribution |
| URO160300 | In distribution | |
| URO180718 | Catheter Gauge 18 Fr | In distribution |
| DYNDT1041 | In distribution | |
| DYND160118 | In distribution | |
| URO160350 | In distribution | |
| DYND160812 | In distribution | |
| DYND160816TS | In distribution | |
| URO170200SQ | In distribution | |
| UROT1035 | In distribution | |
| URO180714CN | Catheter Gauge 14 Fr | In distribution |
| URO4PVCPC16C | In distribution | |
| URO175118C | In distribution | |
| DYND11090 | In distribution | |
| DYND11865 | Catheter Gauge 18 Fr | In distribution |
| DYND11003 | In distribution | |
| DYND160416 | In distribution | |
| DYNDINSERTKIT | In distribution | |
| DYND1518SIL | In distribution | |
| UROT1122 | In distribution | |
| DYNDT1079 | In distribution | |
| URO170816SQ | In distribution | |
| URO170216SQ | Catheter Gauge 16 Fr | In distribution |
| UROT1119 | In distribution | |
| UROT1037 | In distribution | |
| URO170816CQ | Catheter Gauge 16 Fr | In distribution |
| URO170818TS | In distribution | |
| URO170818T | In distribution | |
| URO180100 | In distribution | |
| DYND160814 | In distribution | |
| UROT1056 | Catheter Gauge 16 Fr | In distribution |
| DYND160216 | In distribution | |
| DYND160808T | In distribution | |
| DYND10160 | In distribution | |
| URO170814TQ | In distribution | |
| URO180118 | Catheter Gauge 18 Fr | In distribution |
| URO170716 | In distribution | |
| URO170200S | In distribution | |
| URO180816T | Catheter Gauge 16 Fr | In distribution |
| URO180816TSCN | Catheter Gauge 16 Fr | In distribution |
| DYND10350 | In distribution | |
| DYND11528 | In distribution | |
| URO175818T | In distribution | |
| UROT1043 | Catheter Gauge 18 Fr | In distribution |
| URO170816T | In distribution | |
| DYNDT1042 | In distribution | |
| UROT1118 | In distribution | |
| UROT1028 | Catheter Gauge 18 Fr | In distribution |
| UROT1060 | Catheter Gauge 16 Fr | In distribution |
| UROT1059 | Catheter Gauge 14 Fr | In distribution |
| URO2S0615K | In distribution | |
| URO170816 | In distribution | |
| URO170218C | In distribution | |
| URO170116 | In distribution | |
| URO180806S | Catheter Gauge 6 Fr | In distribution |
| DYND11519 | In distribution | |
| URO170814CQ | Catheter Gauge 14 Fr | In distribution |
| URO180200S | In distribution | |
| URO170814 | In distribution | |
| URO180218 | Catheter Gauge 18 Fr | In distribution |
| URO170810 | In distribution | |
| UROT1049 | Catheter Gauge 18 Fr | In distribution |
| DYND10305 | In distribution | |
| DYND140416 | In distribution | |
| DYNDT1087 | In distribution | |
| UROT1124 | In distribution | |
| UROT1026B | Catheter Gauge 18 Fr | In distribution |
| M102151B | In distribution | |
| DYND11NS14S | In distribution | |
| DYND160116 | In distribution | |
| URO175116C | In distribution | |
| URO170816TSQ | In distribution | |
| URO170518S | In distribution | |
| DYND10407 | In distribution | |
| URO170818TSQ | In distribution | |
| DYND160810T | In distribution | |
| URO170200SCN | In distribution | |
| URO170816G | Catheter Gauge 16 Fr | In distribution |
| UROT1046 | In distribution | |
| URO180816TCN | Catheter Gauge 16 Fr | In distribution |
| URO4POLYPC14 | In distribution | |
| DYND160214 | In distribution | |
| URO170100Q | In distribution | |
| URO170516 | In distribution | |
| DYND160418 | In distribution | |
| DYND10500 | In distribution | |
| URO180718CN | Catheter Gauge 18 Fr | In distribution |
| URO1SPSUM18TD | Catheter Gauge 18 Fr | In distribution |
| UROT1149 | In distribution | |
| URO180216 | Catheter Gauge 16 Fr | In distribution |
| URO170218SG | Catheter Gauge 18 Fr | In distribution |
| UROT1030 | Catheter Gauge 16 Fr | In distribution |
| URO170116G | In distribution | |
| DYND10400 | In distribution | |
| DYND160116C | In distribution | |
| UROT1003 | In distribution | |
| URO4RR14C | In distribution | |
| UROT1098 | Catheter Gauge 14 Fr | In distribution |
| URO4RR16C | In distribution | |
| UROT1041 | Catheter Gauge 16 Fr | In distribution |
| URO180814SCN | Catheter Gauge 14 Fr | In distribution |
| URO180816S | Catheter Gauge 16 Fr | In distribution |
| URO170806T | Catheter Gauge 6 Fr | In distribution |
| DYND160518 | In distribution | |
| DYND160516 | In distribution | |
| URO170218Q | Catheter Gauge 18 Fr | In distribution |
| URO2S1003K | In distribution | |
| URO170818SQ | In distribution | |
| UROT1097 | Catheter Gauge 16 Fr | In distribution |
| URO180816SCN | Catheter Gauge 16 Fr | In distribution |
| URO175114C | In distribution | |
| URO180114 | Catheter Gauge 14 Fr | In distribution |
| URO180816CN | Catheter Gauge 16 Fr | In distribution |
| URO170216 | In distribution | |
| DYND11860 | In distribution | |
| DYND160806 | In distribution | |
| URO180818T | Catheter Gauge 18 Fr | In distribution |
| UROT1057 | Catheter Gauge 18 Fr | In distribution |
| URO170816S | In distribution | |
| URO170816TCN | Catheter Gauge 16 Fr | In distribution |
| UROT1001 | In distribution | |
| URO170818S | In distribution | |
| URO170216Q | Catheter Gauge 16 Fr | In distribution |
| DYND11020 | In distribution | |
| URO4PVCPC14C | In distribution | |
| DYND160810 | In distribution | |
| URO170814Q | In distribution | |
| URO170814TS | In distribution | |
| URO2S0803K | In distribution | |
| UROT1042 | Catheter Gauge 16 Fr | In distribution |
| DYNDT1093 | Catheter Gauge 14 Fr | In distribution |
| URO180814C | In distribution | |
| URO170114Q | Catheter Gauge 14 Fr | In distribution |
| URO170218SQ | Catheter Gauge 18 Fr | In distribution |
| URO170814SQ | In distribution | |
| DYNDT1091 | In distribution | |
| URO1SPSDB14 | In distribution | |
| UROT1009 | In distribution | |
| UROT1121 | In distribution | |
| URO2S1003TK | In distribution | |
| URO170100 | In distribution | |
| URO170818TQ | In distribution | |
| UROT1034 | In distribution | |
| DYND11050 | In distribution | |
| URO1SPLDB14 | In distribution | |
| URO180818 | Catheter Gauge 18 Fr | In distribution |
| UROT1006 | In distribution | |
| DYND11095 | In distribution | |
| URO170808T | Catheter Gauge 8 Fr | In distribution |
| URO170808 | In distribution | |
| URO1SPLDB16 | Catheter Gauge 16 Fr | In distribution |
| DYND11523 | In distribution | |
| UROT1029 | Catheter Gauge 16 Fr | In distribution |
| UROT1004 | In distribution | |
| DYND140216 | In distribution | |
| UROT1002 | In distribution | |
| URO1SPLUM16 | In distribution | |
| UROT1007 | In distribution | |
| URO180808S | Catheter Gauge 8 Fr | In distribution |
| URO170814CQ | Catheter Gauge 14 Fr | In distribution |
| DYNC1816 | In distribution | |
| DYND160814T | In distribution | |
| URO180214 | Catheter Gauge 14 Fr | In distribution |
Showing 250 of 267 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 75 |
| TruAdvance™ | HR Pharmaceuticals Inc. | 29 |
| Cardinal Health | Cardinal Health 200, LLC | 16 |
| VaPro Plus Pocket Kit | Hollister Incorporated | 10 |
| LSL Healthcare | Lsl Industries, Inc. | 8 |
| Duette™ | Poiesis Medical, LLC | 8 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 6 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
| TruCath | HR Pharmaceuticals Inc. | 5 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Closed System Foley Catheter Tray, Pre-Connected Closed Circuit: 12 Fr | Dynarex Corp. | 4 |
| Bardia® Foley Catheter Insertion Tray | C.R. Bard, Inc. | 4 |
Showing 12 of 42. All products under Catheter Care Tray
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-04 | Class II | Nonconforming Material/Component | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached pr | 8327756 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-04 | Class II | Nonconforming Material/Component | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached pr | 4304669 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-04 | Class II | Nonconforming Material/Component | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached pr | 235658 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-04 | Class II | Nonconforming Material/Component | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached pr | 8260 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-05-04 | Class II | Nonconforming Material/Component | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached pr | 10980 units |
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | 60 each |
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.