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