DeRoyal
Collection Set 6 ft PVC Tubing/ 3/8 in Handle and Fitting
51manufacturers in China registered for this device type
19catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (21), Zhejiang (11), Shanghai (9). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Ningbo Mflab Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Guangzhou AMK Medical Equipment Co., Ltd. | Guang Zhou | Guangdong | Contract manufacturer | 10 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
Showing 12 of 51. All 51 manufacturers in China registered for Tube, Aspirating, Flexible, Connecting
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | BYY |
| Device type | Tube, Aspirating, Flexible, Connecting |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-08-23 |
| Record revised | 2021-08-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 20, case of 25, case of 30, case of 40, case of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71-C710 | In distribution | |
| 32-1858 | In distribution | |
| 71-C706 | In distribution | |
| 71-C620 | In distribution | |
| 28-3133C | In distribution | |
| 32-2182 | In distribution | |
| 71-C510 | In distribution | |
| 71-C7100NS | In distribution | |
| 71-C520 | In distribution | |
| 71-C501 | In distribution | |
| 71-C612 | In distribution | |
| 71-C712 | In distribution | |
| 71-C512 | In distribution | |
| 71-C6100NS | In distribution | |
| 71-C606 | In distribution | |
| 71-C5100NS | In distribution | |
| 71-C506 | In distribution | |
| 71-C610 | In distribution | |
| 71-C720 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Conmed | ConMed Corporation | 67 |
| ENT-single-use suction tubes, angled | Spiggle & Theis Medizintechnik Gmbh | 64 |
| AMSure® Suction Connecting Tube | Amsino Medical Inc. | 42 |
| Medline | Medline Industries, Inc. | 33 |
| Connecting Tube | Tianck Medical Co., Ltd. | 15 |
| Tube, Aspirating, Flexible, Connecting | ConMed Corporation | 12 |
| AMSure® Suction Connecting Tube with Pre-Attached Yankauer | Amsino Medical Inc. | 12 |
| Medichoice | Owens & Minor Distribution, Inc. | 12 |
| Centurion | Centurion Medical Products Corporation | 11 |
| Custom Medical Specialties, Inc. | Custom Assemblies, Inc. | 10 |
| RespVac™ | Cutting Edge HC Brands LLC | 10 |
| ProCure | Twin Med, LLC | 9 |
Showing 12 of 129. All products under Tube, Aspirating, Flexible, Connecting
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | UDI-DI | 2025-01-31 | Class II | Under Investigation by firm | Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid p | 714 cases |
| Deroyal Industries, Inc. | UDI-DI | 2025-01-15 | Class II | Device Design | The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care. | 224,770 tubes/connectors |
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.