Bfed™

bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 2 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and…

Registry build 21.09.26

bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 2 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 3 375 mL Bolee™ Bags

17manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Zhejiang (4), Guangdong (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PIF
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
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
Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. Guangzhou Guangdong Contract manufacturer 14
Jiangsu Kangjin Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 13
Ucomfor Scientific Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 13
Primecare Medical (Huzhou) Co., Ltd. Hu Zhou Zhejiang Contract manufacturer 9
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43

Showing 12 of 17. All 17 manufacturers in China registered for Gastrointestinal Tubes With Enteral Specific Connectors

Record

Regulatory record for bFed™
Listed by U Deliver Medical L.L.C., United States
FDA product code PIF
Device type Gastrointestinal Tubes With Enteral Specific Connectors
Device class Class 2
Regulation 21 CFR 876.5980
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K170555
Record published 2018-02-02
Record revised 2018-07-06 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for bFed™
Catalogue number Size Per pack Status
SK-2001 7 In distribution
SK-2002 40 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Micro G-Jet® Applied Medical Technology, Inc. 52
Nutricare Gbuk Group Limited 44
Enteral Gbuk Group Limited 42
Traditional G-Jet® Applied Medical Technology, Inc. 37
Medline Medline Industries, Inc. 22
Kangaroo Cardinal Health 200, LLC 17
Aquarius Degania Silicone, Ltd. 16
AMT Mini ONE® Extension Set Applied Medical Technology, Inc. 16
EndoVive™ One Step Button™ Boston Scientific Corporation 14
Vesco Medical Pediatric Nasogastric Feeding Tubes Cair LGL 13
Kangaroo Cardinal Health 13
Vesco Medical Nasogastric Feeding Tubes Cair LGL 12

Showing 12 of 116. All products under Gastrointestinal Tubes 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