MaxPlus, MaxGuard

Pressure rated T-connector extension set, (minibore) with removable needleless connector 15 cm (6 in)

Registry build 21.09.26
49manufacturers in China registered for this device type
28catalogue 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, MaxGuard
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 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
Storage Storage environment temperature -40 to 125 °F
Packaging Case of 50, case of 600, shelfpack of 50, case of 12, pack or inner pack of 50, box of 50
Sizes Length 5 to 50 in; total volume 0.5 to 1.3 ml
Distribution end date 2023-02-01

Catalogue Numbers

Catalogue numbers for MaxPlus, MaxGuard
Catalogue number Size Status
MX9175 Length 32 in In distribution
MP9202 Total Volume 1.3 ml In distribution
MP9008 In distribution
MP9246-C Length 8 in In distribution
MP9238-C Length 8.5 in In distribution
MP2002-C Total Volume 0.5 ml In distribution
MP9017-B Total Volume 0.75 ml In distribution
MX9178 Length 50 in In distribution
MP2202 Total Volume 1.2 ml In distribution
MPXT1006 Total Volume 1 ml In distribution
MP9239-C Length 7 in In distribution
MPXT5302-C Length 7.5 in In distribution
MP9009 Withdrawn
MP9234-C Withdrawn
MP9212-C Withdrawn
MP9252-C Withdrawn
MP9202-C Withdrawn
MP9204 Withdrawn
MP9224 Withdrawn
MP9227 Withdrawn
MP9208 Withdrawn
MP9277-C Withdrawn
MP9228 Withdrawn
MP2005 Withdrawn
MP9255-C Withdrawn
MP9264-C Withdrawn
MP9247-C Withdrawn
MPXT5301-C 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

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of MaxPlus, MaxGuard
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Carefusion UDI-DI 2021-06-09 Class II Under Investigation by firm A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage. 100 units 2024-07-08

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