Medline Industries, Inc.
1LYRTR 14FR10MLC100%SIL UM SNP
2manufacturers in China registered for this device type
343catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | PPB |
| Device type | Foley Catheter Kit (Excludes Hiv Testing) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Premarket notification | Exempt |
| Record published | 2022-11-30 |
| Record revised | 2022-06-17 (version 7) |
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 20, case of 25, case of 3, case of 8, case of 6 |
| Distribution end date | 2022-03-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| URO175814C | In distribution | |
| URO185718 | In distribution | |
| UROT1082 | In distribution | |
| DYND150218CS | In distribution | |
| URO175516S | In distribution | |
| URO170114 | In distribution | |
| DYNJ63797A | In distribution | |
| URO185816C | In distribution | |
| DYNJ902831D | In distribution | |
| UROT1017 | In distribution | |
| DYND150114 | In distribution | |
| DYND150216S | In distribution | |
| DYNJ903026I | In distribution | |
| DYKE1087G | In distribution | |
| DYKE1030D | In distribution | |
| DYNDT1063C | In distribution | |
| URO170718CN | In distribution | |
| DYNDA1783 | In distribution | |
| URO175200W | In distribution | |
| DYKE1685 | In distribution | |
| DYNJ907822G | In distribution | |
| DYNJ22890M | In distribution | |
| RMS175816T | In distribution | |
| URO185818CS | In distribution | |
| URO175216CS | In distribution | |
| URO185218S | In distribution | |
| DYND160814S | In distribution | |
| URO175218 | In distribution | |
| URO185814T | In distribution | |
| URO175816S | In distribution | |
| URO175816 | In distribution | |
| URO170818CN | In distribution | |
| URO185818T | In distribution | |
| DYND150116 | In distribution | |
| DYKE1514B | In distribution | |
| URO175218CS | In distribution | |
| URO185200S | In distribution | |
| DYKE1798A | In distribution | |
| DYND150214 | In distribution | |
| DYKE1633 | In distribution | |
| DYKE1448 | In distribution | |
| DYKE1012D | In distribution | |
| URO170118Q | In distribution | |
| URO175214 | In distribution | |
| DYKE1674 | In distribution | |
| DYNJ41870B | In distribution | |
| DYNJ68141A | In distribution | |
| DYND150214C | In distribution | |
| URO170814SCN | In distribution | |
| URO175516 | In distribution | |
| URO175714C | In distribution | |
| URO170214Q | In distribution | |
| URO175100W | In distribution | |
| DYND150816 | In distribution | |
| P106730 | In distribution | |
| DYNJ906465 | In distribution | |
| UROT1081 | In distribution | |
| DYKE1740 | In distribution | |
| DYKE1747 | In distribution | |
| DYKE1739 | In distribution | |
| DYND150718C | In distribution | |
| URO175418 | In distribution | |
| DYND10815 | In distribution | |
| URO185818TS | In distribution | |
| DYKE1470A | In distribution | |
| PHS921353000 | In distribution | |
| DYKE1677 | In distribution | |
| URO175816TS | In distribution | |
| DYKE1765 | In distribution | |
| DYKE1653 | In distribution | |
| DYKE1750 | In distribution | |
| DYKE1679 | In distribution | |
| UROT1114 | In distribution | |
| DYND150216C | In distribution | |
| URO170816CCN | In distribution | |
| DYKE1160D | In distribution | |
| DYND160814TS | In distribution | |
| URO175716C | In distribution | |
| URO175218C | In distribution | |
| DYKE1469C | In distribution | |
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| DYND150716C | In distribution | |
| DYNJ62133 | In distribution | |
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| DYND150814S | In distribution | |
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| URO170816SCN | In distribution | |
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| URO185814C | In distribution | |
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| URO185816TS | In distribution | |
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| DYKM1549 | In distribution | |
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| URO185116 | In distribution | |
| DYND150816C | In distribution | |
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| URO185814 | In distribution | |
| DYNJ36728C | In distribution | |
| URO175714 | In distribution | |
| DYKE1768 | In distribution | |
| DYND150216 | In distribution | |
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| URO185816CS | In distribution | |
| CDS984155G | In distribution | |
| UROT1077A | In distribution | |
| DYND150818S | In distribution | |
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| URO170818CS | In distribution | |
| URO1SPSUM18 | In distribution | |
| DYND150200S | In distribution | |
| DYNDT1107A | In distribution | |
| DYND150816CS | In distribution | |
| URO175416 | In distribution | |
| UROT1082A | In distribution | |
| URO175414 | In distribution | |
| DYKE1680B | In distribution | |
| URO170818SCN | In distribution | |
| DYND150814C | In distribution | |
| DYKE1659 | In distribution | |
| URO175518S | In distribution | |
| DYNJ30434I | In distribution | |
| URO175100 | In distribution | |
| URO175518 | In distribution | |
| DYKE1713 | In distribution | |
| DYKE1584A | In distribution | |
| URO175814TS | In distribution | |
| DYKE1298A | In distribution | |
| DYND150716 | In distribution | |
| DYND150518 | In distribution | |
| URO175812TS | In distribution | |
| URO175200S | In distribution | |
| URO170116Q | In distribution | |
| DYKE1727 | In distribution | |
| DYND150514S | In distribution | |
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| URO170814CN | In distribution | |
| DYND150416 | In distribution | |
| DYND150518S | In distribution | |
| DYND150814 | In distribution | |
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| DYNDH2161 | In distribution | |
| DYND150714C | In distribution | |
| URO11855 | In distribution | |
| UROT1078 | In distribution | |
| UROT1081A | In distribution | |
| DYKE1735 | In distribution | |
| DYKE1634 | In distribution | |
| DYKE1668 | In distribution | |
| URO185200 | In distribution | |
| DYKE1671 | In distribution | |
| DYKE1105B | In distribution | |
| DYNDT1025 | In distribution | |
| URO175816CS | In distribution | |
| DYKE1412 | In distribution | |
| DYND150414 | In distribution | |
| DYKE1667 | In distribution | |
| DYKE1649A | In distribution | |
| URO185818S | In distribution | |
| URO175718 | In distribution | |
| DYKE1714 | In distribution | |
| UROT1078A | In distribution | |
| UROT1085 | In distribution | |
| DYKM1548 | In distribution | |
| URO185816S | In distribution | |
| URO185216S | In distribution | |
| URO175214S | In distribution | |
| URO175214C | In distribution | |
| DYKE1708 | In distribution | |
| URO175200 | In distribution | |
| DYND150816T | In distribution | |
| URO175116 | In distribution | |
| URO175814S | In distribution | |
| UROT1112 | In distribution | |
| DYND150814T | In distribution | |
| DYNJ66449 | In distribution | |
| DYKE1726 | In distribution | |
| DYKE1419 | In distribution | |
| DYNJ62557 | In distribution | |
| ARTNC140 | In distribution | |
| URO1SPSDB18 | In distribution | |
| DYND150118 | In distribution | |
| DYKM1453 | In distribution | |
| UROT1080 | In distribution | |
| DYND11855 | In distribution | |
| DYND150818TS | In distribution | |
| DYKE1631C | In distribution | |
| UROT1115 | In distribution | |
| DYKE1651 | In distribution | |
| URO11855A | In distribution | |
| DYNDT1020A | In distribution | |
| URO175216C | In distribution | |
| URO175814 | In distribution | |
| DYND150818T | In distribution | |
| UROT1076A | In distribution | |
| UROT1079 | In distribution | |
| URO170214S | In distribution | |
| DYKE1809A | In distribution | |
| DYKE1410A | In distribution | |
| UROT1084 | In distribution | |
| DYNJ44638C | In distribution | |
| DYND150216CS | In distribution | |
| URO175818 | In distribution | |
| UROT1083 | In distribution | |
| URO175114 | In distribution | |
| DYKE1721 | In distribution | |
| DYKE1672A | In distribution | |
| URO1SPSUM16 | In distribution | |
| DYKE1487C | In distribution | |
| URO170816CSCN | In distribution | |
| DYND150514 | In distribution | |
| URO175814CS | In distribution | |
| LZ7759N | In distribution | |
| DYKM1902 | In distribution | |
| UROT1102 | In distribution | |
| DYKE1654A | In distribution | |
| URO185118 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 6 |
| Dover | Cardinal Health 200, LLC | 6 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 1 |
| Clarity RMS Sensor Tray | RenalSense Ltd. | 1 |
| Cardinal Health | Cardinal Health 200, LLC | 1 |
Recalls Naming This Product
12 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 | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 2153 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 23238 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 23238 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-03 | Class II | Under Investigation by firm | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | 530 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-02-11 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health. | 96 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-21 | Class II | Nonconforming Material/Component | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. | 1086 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-09-04 | Class II | Under Investigation by firm | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. | 8830 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-06-27 | Class II | Process control | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suc | 1616 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-03-22 | Class II | Under Investigation by firm | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | 3400 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 | 1184 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. | 4644 units |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 20 cases (72 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.