DeClogger

DeClogger: Yellow 16-18 French

Registry build 21.09.26
25manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (17), Zhejiang (4), Guangdong (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KNT
Manufacturer City Province Registered as Device types
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Conod Medical Shuyang Co., Ltd. Shuyang Jiangsu Contract manufacturer 22
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. Shuyang Jiangsu Contract manufacturer 18
Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. Guangzhou Guangdong Contract manufacturer 14
Primecare Medical (Huzhou) Co., Ltd. Hu Zhou Zhejiang Contract manufacturer 9
Yangzhou Xingwei Medical Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 5
Tessy Plastics Shanghai Co., Ltd. Shanghai Shanghai Contract manufacturer 4
Flexan (Suzhou) Precision Rubber Products Co., Ltd. Suzhou Jiangsu Contract manufacturer 1
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129

Showing 12 of 25. All 25 manufacturers in China registered for Tubes, Gastrointestinal (And Accessories)

Record

Regulatory record for DeClogger
Listed by Bionix, LLC, United States
FDA product code KNT
Device type Tubes, Gastrointestinal (And Accessories)
Device class Class 2
Regulation 21 CFR 876.5980
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K905164
Record published 2017-03-07
Record revised 2023-11-22 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DeClogger
Catalogue number Size Per pack Status
935 10 In distribution
912 10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Avanos Avanos Medical, Inc. 1,169
Halyard Avanos Medical, Inc. 1,004
G-Jet® Transgastric-Jejunal Feeding Device Applied Medical Technology, Inc. 376
MiniONE Balloon Button Applied Medical Technology, Inc. 373
Mini ONE® Balloon Button Applied Medical Technology, Inc. 336
Kangaroo Cardinal Health 326
NutraGlide Nasal Feeding Tube Applied Medical Technology, Inc. 279
AMT Mini™ Balloon Button Applied Medical Technology, Inc. 231
Vygon Vygon Corp. 229
NeoDevices, Inc. Neodevices Inc 123
Corflo cuBBy Lpgd Corpak Medsystems 98
Kangaroo Cardinal Health 200, LLC 98

Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)

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