Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016413378

FEI Number

3016413378

Entity Name

JIAXING TIANHE PHARMACEUTICAL CO., LTD.

City/State/Country

Jiaxing Zhejiang, CN

Establishment Address

Zhongfa Foreign Trade Industrial Zone, Fengaiao Town, Nanhu District,, Jiaxing Zhejiang 314008, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jiaxing Tianhe Pharmaceutical Co., Ltd. (Owner Number: 10084601)

Owner / Operator Contact Address

Zhongfa Foreign Trade Industrial Zone, Fengqiao Town, Nanhu District,, Jiaxing, CN-ZJ 314008, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AMSafe® Pre-Filled Normal Saline Flush Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2022-03-29
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2022-03-10

Official Correspondent

Holiven Ji

US Agent Details

Gavin Zhang Business: Amsino International Inc. Email: holiven_ji@amsino.com Phone: (909) 6265888

Related Public Records

Same Entity

Jiaxing Tianhe Pharmaceutical Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.

Similar Registrations

Registration Number	Establishment Name	Location
3043709866	HANTECH (NINGBO) MEDICAL TECHNOLOGY CO., LTD.	Ningbo Zhejiang, CN
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3014421917	O&M Halyard, Inc.	Alpharetta, GA, US
3005934752	MEDXL INC	Pointe-Claire Quebec, CA
1911916	BECTON DICKINSON AND COMPANY	COLUMBUS, NE, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016413378. Last updated year: 2026. Please use registration number 3016413378 when referencing this establishment in official correspondence.