Medline Industries, Inc.
Tray, 1LYR 18FR 10ML Latex URN Meter
12manufacturers in China registered for this device type
75catalogue 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 | 2022-07-11 |
| Record revised | 2022-06-17 (version 5) |
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 |
| Packaging | Case of 10, case of 3, case of 20, case of 40, case of 12, case of 4 |
| Sizes | Catheter gauge 6 to 18 Fr; total volume 3 to 10 ml |
| Distribution end date | 2022-03-05 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| URO185100 | In distribution | |
| URO170806TG | In distribution | |
| UROT1016 | In distribution | |
| URO170218G | In distribution | |
| DYNJ66475B | In distribution | |
| URO170808TG | In distribution | |
| DYK1004576X | In distribution | |
| DYND160810T | In distribution | |
| DYNJ17634D | In distribution | |
| DYNJ81597 | In distribution | |
| DYKM1429A | In distribution | |
| DYNDV2480A | In distribution | |
| DYND160806T | Catheter Gauge 6 Fr | In distribution |
| UROT1024 | In distribution | |
| DYNJ80211C | In distribution | |
| URO170810TG | In distribution | |
| URO170816CG | In distribution | |
| URO170814SG | In distribution | |
| CVI4880 | In distribution | |
| URO170818CSQ | In distribution | |
| URO180818CS | In distribution | |
| URO170814G | In distribution | |
| URO170808G | In distribution | |
| URO170816SG | In distribution | |
| DYNDA3068 | In distribution | |
| URO170818CG | In distribution | |
| URO175818C | In distribution | |
| DYND160100 | In distribution | |
| URO170814CSG | In distribution | |
| DYNDA3127 | In distribution | |
| URO170818TSG | In distribution | |
| M102150A | In distribution | |
| URO170216G | In distribution | |
| DYNJ17446C | In distribution | |
| DYNJ908107B | In distribution | |
| URO170806G | In distribution | |
| URO170214G | In distribution | |
| DYNJ65199A | In distribution | |
| DYKM2190 | In distribution | |
| DYNJ61965F | In distribution | |
| DYND160116C | In distribution | |
| DYND160218 | Total Volume 10 ml | In distribution |
| URO170818TG | In distribution | |
| URO170814CG | In distribution | |
| URO170818CSG | In distribution | |
| URO170916 | Catheter Gauge 16 Fr | In distribution |
| ART1225 | In distribution | |
| URO170814CSQ | In distribution | |
| DYNDA2939 | In distribution | |
| CVI3260A | In distribution | |
| URO170816TSG | In distribution | |
| URO170718G | In distribution | |
| URO170218SG | In distribution | |
| URO170714G | In distribution | |
| URO170814TSG | In distribution | |
| URO170818CQ | In distribution | |
| URO170716G | In distribution | |
| URO170114G | In distribution | |
| URO170816CSQ | In distribution | |
| URO170118G | In distribution | |
| URO170810G | In distribution | |
| DYNJ80252C | In distribution | |
| URO170214SG | In distribution | |
| URO170816TG | In distribution | |
| URO170818SG | In distribution | |
| URO170100G | In distribution | |
| URO175818CS | In distribution | |
| ECVC7880 | In distribution | |
| URO170814TG | In distribution | |
| URO170216SG | In distribution | |
| URO170816CSG | In distribution | |
| DYNDV1467A | Withdrawn | |
| DYNDA1430 | Withdrawn | |
| GST128D | Withdrawn | |
| DYNDM1081A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 267 |
| 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
5 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 | 384 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-09-30 | Class II | Under Investigation by firm | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previousl | 12 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-09 | Class II | Under Investigation by firm | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. | 44 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 18 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-05-18 | Class II | Device Design | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 2739 units |
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.