ITL Biomedical

Prefilled Syringe with Saline 0.9%Sodium Chloride(0.9%NaCl),USP Fully Sterile

Registry build 21.09.26
10manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (4), Jiangsu (2), Anhui (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NGT
Manufacturer City Province Registered as Device types
Hantech (Ningbo) Medical Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 3
Jiaxing Tianhe Pharmaceutical Co., Ltd. Jiaxing Zhejiang Contract manufacturer 1
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Jinan Babio Biotechnology Co., Ltd. Jinan Shandong Manufacturer 25
Hantech Medical Device Co., Ltd. Cixi Zhejiang Contract manufacturer 18
Suzhou Cnnc Huadong Radiation Co., Ltd. Suzhou Jiangsu Contract manufacturer 12
Anhui Tiankang Medical Technology Co., Ltd. Tianchang Anhui Contract manufacturer 9
Lucky Star Lrradiation Science Co., Ltd. Shanghai Shanghai Shanghai Contract manufacturer 5
Anhui Tianyang Pharmaceutical Co., Ltd. Tianchang Anhui Manufacturer 1

Record

Regulatory record for ITL Biomedical
Listed by Jiangsu Caina Medical Co., Ltd., China
FDA product code NGT
Device type Saline, Vascular Access Flush
Device class Class 2
Regulation 21 CFR 880.5200
Establishment Contract manufacturer, Manufacturer, Exporter
510(k) K220060
Record published 2025-05-14

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 30, pack of 240

Catalogue Numbers

Catalogue numbers for ITL Biomedical
Catalogue number Size Status
3mL In distribution
5mL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Excelsior Medline Industries, Inc. 28
AMSafe® Pre-Filled Normal Saline Flush Syringe Amsino Medical Inc. 25
Monoject Cardinal Health 19
Nurse Assist Nurse Assist, LLC 13
Ceros Rhino Medical Supply Inc 8
Praxiject™ 0.9% NaCl MedXL 7
McKesson Mckesson Medical-Surgical Inc. 7
Normal Saline IV Flush Syringe Medefil, Inc. 6
Easy Flush SPM Medicare PVT, Ltd. 6
Covidien Nurse Assist, LLC 6
Gbuk Jiangsu Caina Medical Co., Ltd. 5
Cardinal Health Cardinal Health 200, LLC 4

Showing 12 of 35. All products under Saline, Vascular Access Flush

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer