Monoject

Tamper Evident Syringe Bag

Registry build 21.09.26
13manufacturers in China registered for this device type
14catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Zhejiang (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PNR
Manufacturer City Province Registered as Device types
Amsino Medical (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 22
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Chengdu Sichuan Contract manufacturer 10
Anhui Tiankang Medical Technology Co., Ltd. Tianchang Anhui Contract manufacturer 9
Aena Medical (Jiangsu) Co., Ltd. Jiangyin Jiangsu Contract manufacturer 4
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
Hangzhou Best Valley Medical Technology Co., Ltd. Hangzhou Zhejiang Exporter 20
VR Medical Technology Co., Ltd. Kunshan Jiangsu Contract manufacturer 13
Ningbo Tianyi Medical Appliance Co., Ltd. Ningbo Zhejiang Contract manufacturer 11
Shantou Wealy Medical Instrument Co., Ltd. Shantou Guangdong Contract manufacturer 10
Jiangsu Kangbao Medical Equipment Co., Ltd. Yangzhou Jiangsu Contract manufacturer 10
Jiangsu Micsafe Medical Technology Co., Ltd. Yancheng Jiangsu Manufacturer 9

Showing 12 of 13. All 13 manufacturers in China registered for Enteral Syringes With Enteral Specific Connectors

Record

Regulatory record for Monoject
Listed by Cardinal Health, United States
FDA product code PNR
Device type Enteral Syringes With Enteral Specific Connectors
Device class Class 2
Regulation 21 CFR 876.5980
Establishment Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Record published 2016-09-24
Record revised 2024-11-05 (version 14)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number, expiry date
Storage Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT
Packaging Pack_or_inner_pack of 100, pack_or_inner_pack of 30, case of 120, case of 800, case of 400, case of 240
Sizes Total volume 1 to 60 ml
Distribution end date 2030-12-31

Catalogue Numbers

Catalogue numbers for Monoject
Catalogue number Size Per pack Status
460SE Total Volume 60 ml In distribution
406SE Total Volume 6 ml In distribution
46312 250 In distribution
401SE Total Volume 1 ml In distribution
412SE Total Volume 12 ml In distribution
8881112015 1,000 In distribution
435SE Total Volume 35 ml In distribution
8881135015 300 Withdrawn
403SE Withdrawn
8881106015 1,200 Withdrawn
8881101015 3,200 Withdrawn
8881160015 175 Withdrawn
400BE 250 Withdrawn
8881103015 Total Inner Volume,3,Milliliter 2,000 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Enteral Gbuk Group Limited 51
Enteral Syringes With Enteral Specific Connectors Ningbo Tianyi Medical Appliance Co., Ltd. 48
Kbmed KB Medical (Group) Inc. 31
ENFit Syringe Avanos Medical, Inc. 30
Health Care Logistics, Inc® Health Care Logistics, Inc. 24
Ameritus ENFit Kentec Medical, LLC 22
NeoConnect Pharmacy Syringe Neomed Co., Ltd. 21
Monoject Cardinal Health 200, LLC 19
NeoConnect Oral / Enteral Syringe Neomed Co., Ltd. 16
Medline Medline Industries, Inc. 16
micsafe Jiangsu Micsafe Medical Tehcnology Co., Ltd. 13
Avanos Avanos Medical, Inc. 12

Showing 12 of 70. All products under Enteral Syringes With Enteral Specific Connectors

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