Cardinal Health
Lubricated Intubating Stylet, 14Fr, 3.5mm
34manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (10), Jiangsu (9), Guangdong (8). 11 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 Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Hangzhou Formed Medical Devices Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| Tianjin Medis Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
Showing 12 of 34. All 34 manufacturers in China registered for Stylet, Tracheal Tube
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | BSR |
| Device type | Stylet, Tracheal Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5790 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-14 |
| Record revised | 2022-12-20 (version 4) |
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 10, box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IS10FRL | In distribution | |
| IS12L | In distribution | |
| IS6FRL | In distribution | |
| IS14L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SunMed | SunMed Group Holdings, LLC | 22 |
| Stylet, Tracheal Tube | VBM Medizintechnik Gmbh | 17 |
| Hudson RCI | Teleflex Medical LLC | 16 |
| SourceMark | Sourcemark, LLC. | 13 |
| Intubating Stylet | Well Lead Medical Co., Ltd. | 11 |
| AincA® | Anesthesia Associates, Inc. | 8 |
| Medline | Medline Industries, Inc. | 8 |
| Sheridan | Teleflex Medical LLC | 7 |
| Rusch | Teleflex Medical LLC | 6 |
| Anesthesia | Sunset Healthcare Solutions, Inc. | 4 |
| Vital Signs™ | Airlife, Inc. | 4 |
| Portex | ICU Medical, Inc | 4 |
Showing 12 of 86. All products under Stylet, Tracheal Tube
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 | Closed |
|---|---|---|---|---|---|
| 2014-12-23 | Class II | Process control | A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube. | 104,432 stylets | 2016-08-01 |
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.