NeoConnect Oral / Enteral Syringe, OTC

60mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC

Registry build 21.09.26
13manufacturers in China registered for this device type
4catalogue numbers in this listing
4510(k) clearances naming this product code

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 NeoConnect Oral / Enteral Syringe, OTC
Listed by Neomed Co., Ltd., South Korea
FDA product code PNR
Device type Enteral Syringes With Enteral Specific Connectors
Device class Class 2
Regulation 21 CFR 876.5980
Establishment Manufacturer
Record published 2019-09-06
Record revised 2021-10-29 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Shipper of 16, case of 10, shipper of 10, case of 15, case of 25, case of 50

Catalogue Numbers

Catalogue numbers for NeoConnect Oral / Enteral Syringe, OTC
Catalogue number Size Status
Neo60 In distribution
Neo12 In distribution
Neo6 In distribution
Neo3 In distribution

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
Monoject Cardinal Health 14
micsafe Jiangsu Micsafe Medical Tehcnology Co., Ltd. 13

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K183540 2019-04-30
K161039 2016-06-17
K152857 2015-12-17
K143344 2015-04-09

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