VentiSeal Prefromed Nasal North(PNN)ET Tube ID 8.5mm – Steri
Catalogue number 038-974-085U, listed by Flexicare Medical Ltd., United Kingdom, under Tube, Tracheal (W/Wo Connector). 9 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Jiangxi Yikang Medical Instrument Group Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Qingdao Traworks Co., Ltd. | Qingdao | Shandong | Exporter | 7 |
| Tianjin Medis Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Chilecom Medical Devices Co Ltd | Xiangtan | Hunan | Manufacturer | 5 |
Record
| Listed by | Flexicare Medical Ltd., United Kingdom |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-10-04 |
| Record revised | 2024-12-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 038-974-085U | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 301 |
| Shiley | Covidien LP | 295 |
| Mallinckrodt | Covidien LP | 258 |
| Hudson RCI | Teleflex Medical LLC | 241 |
| Portex | ICU Medical, Inc | 208 |
| Parker Flex-Tip | Salter Labs | 164 |
| Parker | Salter Labs | 157 |
| Curaplex | Bound Tree Medical, LLC | 149 |
| SourceMark | Sourcemark, LLC. | 148 |
| Montgomery® Safe-T-Tube™ | Boston Medical Products, Inc. | 144 |
| Sunmed | SunMed Group Holdings, LLC | 112 |
| Forsure | Forsure Medical Products LLC. | 101 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250243 | 2025-05-20 |
| K091591 | 2009-06-17 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-09-22 | Class I | Component design/selection | When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient. | 2087 | 2024-07-29 |
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.