Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006157842

FEI Number

3006157842

Entity Name

ASIA CONNECTION CO., LTD.

City/State/Country

New Taipei City, TW

Establishment Address

16F-1, No.16, Jian Ba Road, Chung Ho District,, New Taipei City 235603, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ASIA CONNECTION CO., LTD. (Owner Number: 10022874)

Owner / Operator Contact Address

16F-1, No.16, Jian Ba Road,, Chung Ho District, New Taipei City, TW-NOTA 235603, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

N95 Particulate Respirators Nebulizer Kit ME4437 Egg-shaped Manual Nasal Aspirator ME4438 Acorn-shaped Manual Nasal Aspirator ME8202X Battery Operated Nasal Aspirator ME4439 Pen-shaped Manual Nasal Aspirator MS001 Auto-Bulb Manual Nasal Aspirator MS002 Hand Pump Manual Nasal Aspirator Eustachi Ear Pressure Relief Device Instand Hot Pack, Instant Cold Pack Instant ear thermometer, Fahrenheit & Celsius scales Twin port mask with one valve Guedel airways Airways Berman airways Two-Piece Connector Bandage Scissors Cuffed/ Uncuffed Endotracheal Tube with Style Cuffed/Uncuffed Endotracheal Tube Mouthpiece, breathing AIRWAY, NASOPHARYNGEAL Manual Stethoscope Endotracheal tube Anesthesia Breathing Circuit Kit (Adult & Pediatric) Oxygen Connecting Tube CPR Board Thermometer, Electronic, Clinical Pocket Resuscitator CPR mask Chemo Gown; Coverall with tape; Disposable Coverall; Disposable Isolation Gown Tube Type Flow Meter Splint Air cushion mask Silicone stomach tube Compressor Nebulizer Disposable PVC Resuscitator, Disposable PEEP Valve, Disposable Manometer Polymer patient examination gloves Body Strap Kit Head Harness for child Head Harness for infat Head Harness for adult Oxygen cylinder, Oxygen regulator, Oxygen Flow meter Suction Connecting Tube Yankauer Handle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-25
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-08-30
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2010-12-17
MJV	Device, Inflation, Middle Ear	Unknown	Class U	N/A	2021-05-10
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2013-04-15
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2012-04-20
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2012-12-18
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2015-03-16
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2015-03-16
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2008-10-28
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2013-09-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-10-17
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-04-15
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2007-10-17
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2014-02-11
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2008-01-17
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-10-28
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2010-10-15
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2011-03-03
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2007-10-17
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2026-02-02
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2017-12-11
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2019-11-29
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2020-08-12
FOA	Board, Cardiopulmonary	General Hospital	Class 1	880.6080	2012-05-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-07-22
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-10-17
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-08-24
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2014-02-11
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2010-12-03
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2013-04-15
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2007-10-17
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-07-31
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2013-08-12
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2013-06-02
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2016-07-13
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2016-07-13
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2008-10-28
BXO	Transducer, Gas Pressure	Anesthesiology	Class 1	868.2900	2010-09-13
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2020-04-15
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2020-04-15
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2020-04-15
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-05-17
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2020-10-19
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2020-12-17
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2007-10-17
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2012-05-02
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2019-12-17
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2009-12-17
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2009-12-17

Official Correspondent

Sam Lee

US Agent Details

Jerry Doane Business: FDAbasics LLC Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

ASIA CONNECTION 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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
Z-0043-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006157842. Last updated year: 2026. Please use registration number 3006157842 when referencing this establishment in official correspondence.