Tubing, Noninvasive
Smoke Evacuation Tubing (Non-Sterile) 7/8 in (22mm) to 1/4 in (6.4mm) reducer fitting with 2 ft (.6m) x 1.4 in (6.4mm) tubing
33manufacturers in China registered for this device type
19catalogue 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 | ConMed Corporation, United States |
|---|---|
| FDA product code | GAZ |
| Device type | Tubing, Noninvasive |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-10-16 |
| Record revised | 2024-05-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: KEEP DRY; Storage environment atmospheric pressure 0.5 to 1.06 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature -25 to 70 °C |
| Packaging | Box of 10, box of 24, box of 5, box of 12, box of 6 |
| Distribution end date | 2021-11-18 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| VT10524-10 | 10 | In distribution | |
| QS0024 | 24 | In distribution | |
| RF10512 | 12 | In distribution | |
| ST10105 | 5 | In distribution | |
| RF10110 | 10 | In distribution | |
| VT10510 | 10 | In distribution | |
| VT10106 | 6 | In distribution | |
| RF10705 | 5 | In distribution | |
| QS0023 | In distribution | ||
| RF13810 | 10 | In distribution | |
| RF783824 | 24 | In distribution | |
| RF12524 | 24 | In distribution | |
| QS0026 | In distribution | ||
| QS0025 | In distribution | ||
| VT10610 | 10 | In distribution | |
| 57525338 | Withdrawn | ||
| QS0023 | 24 | Withdrawn | |
| QS0025 | 5 | Withdrawn | |
| QS0026 | 12 | Withdrawn |
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 |
| Custom Medical Specialties, Inc. | Custom Assemblies, Inc. | 19 |
| Silicone Tubing | Invotec International, Inc. | 19 |
| Welmed | Welmed, Inc. | 18 |
| Axiom® | Axiom Medical, Inc. | 16 |
| Bemis | Bemis Manufacturing Co. | 14 |
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 | Closed |
|---|---|---|---|---|
| 2016-06-27 | Class II | Under Investigation by firm | The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. | 2018-06-07 |
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.