Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013513837

FEI Number

3013513837

Entity Name

Tylenol Medical Instruments Co., Ltd.

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

3rd Floor, No.10, Xinhua Road, Sanjiao Town,, Zhongshan Guangdong 528445, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Tylenol Medical Instruments Co., Ltd. (Owner Number: 10057256)

Owner / Operator Contact Address

3rd Floor, No.10, Xinhua Road, Sanjiao Town, Zhongshan, CN-GD 528445, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Urine collector Non-rebreath Masks suction tubing Tylenolmed, disposal medical mask, non-sterile Tylenolmed, disposable medical mask, non-sterile MASS SPECTROMETRY MONITORING LINE CONONECTORS Tylenol suction handle Tylenol, Oxygen Masks, Adult standard, Pediatric standard, Adult elongated, Pediatric elongated Aerosol Mask, model Adult Standard, Pediatric Standard, Adult Elongated, Pediatric Elongated analyzer, gas, carbon-dioxide, gaseous-phase Tylenolmed, KN95 Protective Mask, TN-101 Tylenolmed, disposable medical mask, non-sterile Urine bag ANESTHETIC MASK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFH	Collector, Urine, Pediatric, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2018-05-06
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2018-03-27
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2018-05-06
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-09
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2024-11-18
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2019-03-01
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2018-03-13
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-06-19
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-11
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2018-05-06
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2018-03-27

Official Correspondent

Bin Liu

US Agent Details

Peter Yang Business: JIAMEI CONSULTING INC. Email: info@jiameiconsulting.com Phone: (310) 2168437

Related Public Records

Same Entity

Tylenol Medical Instruments Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013513837. Last updated year: 2026. Please use registration number 3013513837 when referencing this establishment in official correspondence.