DeRoyal
Suction/Irrigation Tubing
33manufacturers in China registered for this device type
6catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (13), Zhejiang (7), Guangdong (6). 12 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 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd. | Jintan | Jiangsu | Contract manufacturer | 10 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Anhui Careplus Medical Technology Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 6 |
| Dong Guan Queenmed Equipment MFG Co Ltd | Dongguan | Guangdong | Contract manufacturer | 2 |
| Suzhou Jinsheng Plastic Co., Ltd. (Zhibei Branch) | Suzhou | Jiangsu | Contract manufacturer | 2 |
Showing 12 of 33. All 33 manufacturers in China registered for Tubing, Noninvasive
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | GAZ |
| Device type | Tubing, Noninvasive |
| 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 | 2016-09-12 |
| Record revised | 2019-04-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 25, case of 20, case of 50, case of 40, box of 2 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31-005 | In distribution | |
| 32-1393 | In distribution | |
| 32-1493 | In distribution | |
| 32-2085 | In distribution | |
| 32-1394 | In distribution | |
| 32-1492 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 78 |
| Argyle | Cardinal Health | 71 |
| Buffalo Filter | Buffalo Filter Co., Inc. | 46 |
| Argyle | Cardinal Health 200, LLC | 35 |
| Medline | Medline Industries, Inc. | 27 |
| Conmed Buffalo Filter | ConMed Corporation | 20 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 20 |
| Tubing, Noninvasive | ConMed Corporation | 19 |
| Custom Medical Specialties, Inc. | Custom Assemblies, Inc. | 19 |
| Silicone Tubing | Invotec International, Inc. | 19 |
| Welmed | Welmed, Inc. | 18 |
| Axiom® | Axiom Medical, Inc. | 16 |
Showing 12 of 124. All products under Tubing, Noninvasive
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 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 |
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.