Tylenol Medical Instruments Co., Ltd.
Registered establishment in Zhongshan, Guangdong, China. 15 device types, 1 clearance.
Tylenol Medical Instruments Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Respirator, Surgical and 13 other device types. Its earliest product listing with the FDA dates from 2018.
15device types registered with the FDA
1510(k) clearance
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3013513837 |
| FEI number | 3013513837 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 中山市泰诺医疗器械有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Zhongshan |
|---|---|
| Province | Guangdong |
| Address | 3rd Floor, No.10, Xinhua Road, Sanjiao Town, |
| Postal code | 528445 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Tylenolmed, disposable medical mask, non-sterile, Tylenolmed, KN95 Protective Mask, TN-101 | 2020 | 439 |
| Airway, Nasopharyngeal | Class 1 | Airway, Nasopharyngeal | 2018 | 52 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Airway, Oropharyngeal | 2018 | 84 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | analyzer, gas, carbon-dioxide, gaseous-phase, Tylenol CO2 Sampling Line, Mass Spectrometry Monitoring Line Cononectors | 2019 | 29 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Urine bag | 2018 | 52 |
| Cannula, Nasal, Oxygen | Class 1 | Nasal Oxygen Cannulas | 2018 | 97 |
| Catheter And Tip, Suction | Class 2 | Tylenol suction handle | 2019 | 70 |
| Catheters, Suction, Tracheobronchial | Class 1 | Suction Catheters | 2018 | 93 |
| Collector, Urine, Pediatric, For Indwelling Catheter | Class 2 | Urine collector | 2018 | 11 |
| Mask, Gas, Anesthetic | Class 1 | Anesthetic Mask | 2018 | 71 |
| Mask, Oxygen | Class 1 | Tylenol, Oxygen Masks, Adult standard, Pediatric standard, Adult elongated, Pediatric elongated, Aerosol Mask, model Adult Standard, Pediatric Standard, Adult Elongated, Pediatric Elongated | 2018 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Multi-vent Masks | 2018 | 46 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Non-rebreath Masks | 2018 | 72 |
| Respirator, Surgical | Class 2 | Tylenolmed, disposal medical mask, non-sterile, Tylenolmed, disposable medical mask, non-sterile | 2020 | 118 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | suction tubing | 2018 | 51 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K181981 | 2019-02-06 | CCK | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | oxygen masks, nebulizer masks, nasal oxygen cannula, endotracheal tubes, foley catheters |
| Certifications | ISO 13485, CE |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.