MediBag

MediBag - 500 mL - Dual Port (Needleless and Spike Ports)

Registry build 21.09.26
7manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KPE
Manufacturer City Province Registered as Device types
Ming FAI Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
Yangzhou Xingwei Medical Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 5
Wanying Health & Technology (Zhongshan) Co., Ltd. Zhongshan Guangdong Contract manufacturer 3
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Ming FAI Enterprise International Co., Ltd. Kowloon Hong Kong Exporter 18
Yangzhou Weideli Trading Co., Ltd. Yangzhou Jiangsu Contract manufacturer 10
Beijing L&Z Medical Technology Development Co., Ltd. Beijing Beijing Manufacturer 2

Record

Regulatory record for MediBag
Listed by Summit Medical Products, Inc., United States
FDA product code KPE
Device type Container, I.V.
Device class Class 2
Regulation 21 CFR 880.5025
510(k) K001287
Record published 2016-09-09
Record revised 2019-10-07 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Pack of 60, pack of 30
Sizes Total volume 100 to 500 ml

Catalogue Numbers

Catalogue numbers for MediBag
Catalogue number Size Status
220121 Total Volume 250 ml In distribution
220582 Total Volume 420 ml In distribution
220533 Total Volume 100 ml In distribution
220278 Total Volume 420 ml In distribution
220524 Total Volume 250 ml In distribution
220529 Total Volume 250 ml In distribution
220530 Total Volume 500 ml In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ChemoPlus Cardinal Health 54
Secure® Metrix Company, THE 46
EVA TPN Bags Valmed SRL 45
ChemoPlus Cardinal Health 200, LLC 44
Container, I.V. Metrix Company, THE 27
EcoFLX™ Empty Mixing Container Douglas Medical Products, Inc 22
Cormix Metrix Company, THE 21
PiSA BioPharm Pisa Biopharm Inc. 20
Pinnacle® B. Braun Medical Inc. 20
Apex® B. Braun Medical Inc. 18
Acta Medical Acta Medical, LLC 17
McKesson Mckesson Medical-Surgical Inc. 14

Showing 12 of 59. All products under Container, I.V.

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