MaxPlus

Pressure rated bi-fuse extension set, (minibore) with two removable clear needleless connectors 21 cm (8.375 in)

Registry build 21.09.26
49manufacturers in China registered for this device type
30catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FPA
Manufacturer City Province Registered as Device types
Promisemed Hangzhou Meditech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 21
Hantech Medical Device Co., Ltd. Cixi Zhejiang Contract manufacturer 18
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13
Ningbo Tianyi Medical Appliance Co., Ltd. Ningbo Zhejiang Contract manufacturer 11
Anhui Tiankang Medical Technology Co., Ltd. Tianchang Anhui Contract manufacturer 9
Anhui Kangda Medical Products Co., Ltd. Tianchang Anhui Contract manufacturer 7
JDI Electronics Factory Dongguan Guangdong Contract manufacturer 7
Yangzhou Xingwei Medical Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 5
Wenzhou K.L.F. Medical Plastics Co., Ltd. Wenzhou Zhejiang Contract manufacturer 4
Advance Technology Ltd Shenzhen Guangdong Contract manufacturer 3
Weihai Jierui Medical Products Co., Ltd. Weihai Shandong Contract manufacturer 3

Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular

Record

Regulatory record for MaxPlus
Listed by BD Switzerland Sàrl
FDA product code FPA
Device type Set, Administration, Intravascular
Device class Class 2
Regulation 21 CFR 880.5440
Record published 2016-11-04
Record revised 2024-07-23 (version 8)

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
Storage Special storage condition: Keep dry; Special storage condition: Fragile, handle with care; Special storage condition: Keep away from sunlight; Storage environment temperature -40 to 125 °F
Packaging Box of 50, case of 600, shelfpack of 50, case of 50, case of 12, pack or inner pack of 50
Sizes Length 7 to 13 in; total volume 0.6 to 0.8 ml
Distribution end date 2023-02-01

Catalogue Numbers

Catalogue numbers for MaxPlus
Catalogue number Size Status
MP5304-C Length 7 in In distribution
MP5314-C Length 7 in In distribution
MP5313-C Length 8.5 in In distribution
MPX9108-C Length 13 in In distribution
MPX9103 Length 8 in In distribution
MP1000-C In distribution
MPX5300-C Length 9 in In distribution
MP5301-C Total Volume 0.8 ml In distribution
MP5315-C Length 8.375 in In distribution
MPX5302-C Length 9 in In distribution
MPX5301-C Length 7.5 in In distribution
MPX5305-C Length 7.5 in In distribution
MP5301 Total Volume 0.7 ml In distribution
MP5302-C Flow Rate = 10 millilitre per second (mL/s) In distribution
MPX5304-C Length 11 in In distribution
MP1000 In distribution
MP5302 Total Volume 0.6 ml In distribution
MP5303-C Length 7.5 in In distribution
MP5310-C Length 8.5 in In distribution
MP5312-C Length 8.5 in In distribution
MP5305-C Length 7 in In distribution
MP5311-C Withdrawn
MP5002 Withdrawn
MP5303 Withdrawn
MPX9100 Withdrawn
MP5004 Withdrawn
MPX9105 Withdrawn
MPX9102-SF-C Withdrawn
MP9017-C Length 12 in Withdrawn
MPX9104 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ICU Medical ICU Medical, Inc 529
Codan Codan US Corp. 510
Vygon Vygon Corp. 355
Port Access Needle Bard Access Systems, Inc. 341
Set, Administration, Intravascular Mps Medical, Inc. 291
Alaris, SmartSite BD Switzerland Sàrl 266
IV Administration Set B. Braun Medical Inc. 242
Medex ICU Medical, Inc 237
Extension Set B. Braun Medical Inc. 171
MaxGuard BD Switzerland Sàrl 150
Medline Medline Industries, Inc. 148
Centurion Centurion Medical Products Corporation 145

Showing 12 of 768. All products under Set, Administration, Intravascular

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of MaxPlus
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
BD Switzerland Sarl UDI-DI 2026-06-16 Class II Process control Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly. 93,700
Becton, Dickinson & Co. UDI-DI 2019-05-02 Class II Under Investigation by firm After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or
permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes
undetected, espe
115,200 2021-11-30

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