Monoject

3 mL Oral Syringe Amber Amber Ribbed Tip Cap

Registry build 21.09.26
68manufacturers in China registered for this device type
13catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (14), Zhejiang (13), Shanghai (12). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KYW
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Hynaut Health Technology Co., Ltd. Qingdao Shandong Contract manufacturer 68
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Biomed Plastics Co. Taicang Jiangsu Contract manufacturer 29
Hangzhou Dunli Medical Instruments Co., Ltd. Hangzhou Zhejiang Contract manufacturer 16
Tung Hing Plastic & Metal(Shenzhen) Co., Ltd. Longgang Dist, Shenzhen Guangdong Contract manufacturer 15
Meifu Medical Technology Suzhou Co., Ltd. Suzhou Jiangsu Contract manufacturer 13
Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd Foshan Guangdong Contract manufacturer 11
JIE GAO Plastic Products Co., Ltd. Dongguan Guangdong Contract manufacturer 11
Shantou Wealy Medical Instrument Co., Ltd. Shantou Guangdong Contract manufacturer 10
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Chengdu Sichuan Contract manufacturer 10
Yangzhou Yichuan Plastic Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 8

Showing 12 of 68. All 68 manufacturers in China registered for Container, Liquid Medication, Graduated

Record

Regulatory record for Monoject
Listed by Cardinal Health 200, LLC, United States
FDA product code KYW
Device type Container, Liquid Medication, Graduated
Device class Class 1
Regulation 21 CFR 880.6430
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-05-20
Record revised 2026-06-02 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 5
Sizes Total volume 1 to 3 ml
Distribution end date 2025-12-31

Catalogue Numbers

Catalogue numbers for Monoject
Catalogue number Size Per pack Status
8881907102 100 In distribution
8881901006 100 In distribution
8881906005 100 In distribution
8881903002 Total Volume 3 ml 100 In distribution
8881901014 100 In distribution
8881906104 100 In distribution
8881907003 100 In distribution
8881903010 Total Volume 3 ml 100 In distribution
8881901006 100 Withdrawn
8881907199 480 Withdrawn
8881906104 100 Withdrawn
8881901014 Total Volume 1 ml 100 Withdrawn
8881906005 100 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Health Care Logistics, Inc® Health Care Logistics, Inc. 57
Bioseal Inc. Bioseal 17
Monoject Cardinal Health 16
CHS Canadian Hospital Specialties Ltd. 15
Marina Medical Marina Medical Instruments, Inc. 13
Avaline Medical NJ LLC Avaline Medical NJ Limited Liability Company 12
Medegen Medical Products, LLC Medegen Medical Products 11
BD Oral Syringe Becton, Dickinson AND Company 8
V. Mueller Steris Corporation 8
Alleset GRI Medical & Electronic Technology Co., Ltd. 8
Cardinal Health Cardinal Health 200, LLC 8
MSI Precision Specialty Instruments MED Saver, Inc. 6

Showing 12 of 60. All products under Container, Liquid Medication, Graduated

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