Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012348048

FEI Number

3012348048

Entity Name

Amphenol (Changzhou) Connector Systems Co., Ltd.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

Building 10A, Jintong Industrial Park, No. 8 Xihu Road, Wujin High-Tech Development Zone, Changzhou Jiangsu 213164, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Amphenol Thermometrics, Inc. (Owner Number: 10052376)

Owner / Operator Contact Address

967 Windfall Road, Saint Marys, PA 15857, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2021-10-21
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2016-08-09
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2016-08-09
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2019-01-03

Official Correspondent

John Lukie

US Agent Details

John Lukie Business: AMPHENOL THERMOMETRICS, INC. Email: john.lukie@amphenol-sensors.com Phone: (732) 2364913

Related Public Records

Same Entity

Amphenol Thermometrics, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008956776	AMPHENOL THERMOMETRICS, INC.	Saint Marys, PA, US
3005934741	Thermometrics Mexico, S.A. de C.V	Tijuana Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020219	Replacement Parts Industries, Inc.	RPI SKIN OR AIR TEMPERATURE PROBE	2002-04-12
K881713	Gempco, Inc.	SPECIAL PROCEDURES BASE UNIT MODEL 500	1988-07-12
K943360	Ohmeda Medical	OHIO CARE PLUS INCUBATOR	1994-09-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2020	Ohmeda Medical	2	Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Similar Registrations

Registration Number	Establishment Name	Location
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1057358	RG Medical USA	Mount Juliet, TN, US
2085602	FISHER & PAYKEL HEALTHCARE, INC.	IRVINE, CA, US
3004050971	VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD.	Dong Guan City Guangdong, CN
2510954	DRAEGER MEDICAL SYSTEMS, INC.	Telford, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012348048. Last updated year: 2026. Please use registration number 3012348048 when referencing this establishment in official correspondence.