Alaris
PCA Administration Kit Reusable Monoject Plunger Rod, Kit Contents: Administration Set, Model 30853 with: Microbore Tubing Segment, Check Valve, Anti-siphon Valve, Reusable Monoject Plunger…
PCA Administration Kit Reusable Monoject Plunger Rod, Kit Contents: Administration Set, Model 30853 with: Microbore Tubing Segment, Check Valve, Anti-siphon Valve, Reusable Monoject Plunger Rod (Compatible with Monoject Syringe Barrel) 178 cm (70 in)
49manufacturers in China registered for this device type
122catalogue 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.
| 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 |
| Premarket notification | Exempt |
| Record published | 2016-09-22 |
| Record revised | 2025-12-22 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -40 to 125 °F |
| Packaging | Case of 100, case of 20, case of 50, case of 72, case of 10, case of 30 |
| Sizes | Length 5 to 234 in |
| Distribution end date | 2023-02-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10010525 | Length 30 in | In distribution |
| 10015817 | Length 8 in | In distribution |
| MS3500 | Length 36 in | In distribution |
| 25206 | Length 32 in | In distribution |
| 10321214 | Length 79 in | In distribution |
| 10014915 | Length 36 in | In distribution |
| 10016242 | Length 32 in | In distribution |
| 10373772 | Length 6 in | In distribution |
| 20022 | Length 60 in | In distribution |
| 10010483 | Length 82 in | In distribution |
| 10013203 | Length 39 in | In distribution |
| 2220-0500 | Length 121 in | In distribution |
| 2941-0500 | Length 39 in | In distribution |
| 10839681 | Length 7 in | In distribution |
| 10013890 | Length 44 in | In distribution |
| 11448964 | Length 36 in | In distribution |
| C25012 | Size = Priming Volume = 0.5 millilitre (mL) | In distribution |
| C25006 | Length 84 in | In distribution |
| 2207-0007 | Length 118 in | In distribution |
| 25203 | Length 20 in | In distribution |
| 2202-0500 | Length 110 in | In distribution |
| 2260-0500 | Length 113 in | In distribution |
| 10800173 | Length 70 in | In distribution |
| 2278-0500 | Length 121 in | In distribution |
| 10014914 | Length 60 in | In distribution |
| 10010985 | Length 33 in | In distribution |
| 10013364T | Size = Priming Volume = 12 millilitre (mL) | In distribution |
| 10015485 | Length 8 in | In distribution |
| 2430-0500 | Size = Priming Volume = 27 millilitre (mL) | In distribution |
| 10800176 | Length 92 in | In distribution |
| C20022 | Length 20 in | In distribution |
| 11426964 | Length 47 in | In distribution |
| 10014913 | Length 36 in | In distribution |
| 10014916 | Length 60 in | In distribution |
| 10014917 | Length 60 in | In distribution |
| 11612593 | Length 112 in | In distribution |
| 10062818 | Length 122 in | In distribution |
| 30862-0500 | Length 62 in | In distribution |
| 70200 | In distribution | |
| 10800174 | Length 63 in | In distribution |
| 30873 | In distribution | |
| 2241-0008 | Length 132 in | In distribution |
| 25205 | Length 32 in | In distribution |
| 10012213 | Length 60 in | In distribution |
| 10863358 | Length 117 in | In distribution |
| 10137407 | In distribution | |
| 10387509 | Length 105 in | In distribution |
| 10011301 | Length 119 in | In distribution |
| 10014918 | Length 60 in | In distribution |
| 70000N-07 | Length 31 in | In distribution |
| 10241342 | Length 62 in | In distribution |
| 10800175 | Length 90 in | In distribution |
| 30883 | Length 92 in | In distribution |
| 2206-0007 | Length 98 in | In distribution |
| 2200-0500 | Length 109 in | In distribution |
| 30893 | In distribution | |
| 10014081 | Length 32 in | In distribution |
| 10015501 | Length 28 in | In distribution |
| 9387-0500 | Length 41 in | In distribution |
| C24117 | Length 113 in | In distribution |
| 11582774 | Length 36 in | In distribution |
| 82113 | Length 22 in | In distribution |
| 10844551 | Length 55 in | In distribution |
| 11088483 | Length 62 in | In distribution |
| 10798697 | Length 63 in | In distribution |
| 11619231 | Length 47 in | In distribution |
| 42000 | Length 104 in | In distribution |
| 11608375 | Length 21 in | In distribution |
| 2440-0600 | Size = Priming Volume = 22 millilitre (mL) | In distribution |
| C42001 | Length 90 in | In distribution |
| 10010761 | Length 94 in | In distribution |
| C20025 | Length 8 in | In distribution |
| 10912433 | Length 48 in | In distribution |
| 30853 | Length 70 in | In distribution |
| 10798703 | Size = Priming Volume = 11 millilitre (mL) | In distribution |
| 9987-0000 | Length 41 in | In distribution |
| 72213N | Length 31 in | In distribution |
| C24112 | Length 26 in | In distribution |
| 10015612 | Length 78 in | In distribution |
| 10942011 | Length 109 in | In distribution |
| C20032 | In distribution | |
| 10011865 | Length 7 in | In distribution |
| 2211-0500 | Length 118 in | In distribution |
| C70101 | Length 36 in | In distribution |
| 30914 | Length 60 in | In distribution |
| 10015414 | Length 126 in | In distribution |
| 10011881 | Length 40 in | In distribution |
| 10026685 | Length 8 in | In distribution |
| 10031776 | Length 234 in | In distribution |
| C20016 | Length 30 in | In distribution |
| 30863 | Length 63 in | In distribution |
| 30822 | Length 62 in | In distribution |
| 10015487 | In distribution | |
| 10800177 | In distribution | |
| 10794983 | Length 7 in | In distribution |
| 2442-0007 | Length 130 in | In distribution |
| 10896354 | Length 110 in | In distribution |
| 2202-0007 | Length 122 in | In distribution |
| C30006 | Size = Priming Volume = 1.6 millilitre (mL) | In distribution |
| 10015492 | Length 104 in | In distribution |
| 2210-0500 | Length 116 in | In distribution |
| 2232-0007 | Length 119 in | In distribution |
| 10012866 | Length 17 in | In distribution |
| 30893-07 | In distribution | |
| 20129E | Length 7 in | In distribution |
| 2204-0007 | Length 47 in | In distribution |
| 2280-0000 | Length 80 in | In distribution |
| 2203-0500 | Length 110 in | In distribution |
| 72213 | Length 33 in | In distribution |
| 30910 | Length 36 in | In distribution |
| C20014 | Length 30 in | In distribution |
| 10010570 | Length 60 in | In distribution |
| 10014472 | Length 45 in | In distribution |
| 11620791 | Withdrawn | |
| 2942-0500 | Withdrawn | |
| 2230-0500 | Withdrawn | |
| 42085 | Withdrawn | |
| 70001N-07 | Withdrawn | |
| 11258587 | Withdrawn | |
| 2270-0500 | Withdrawn | |
| 2231-0500 | Withdrawn | |
| 2264-0500 | 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
6 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 |
|---|---|---|---|---|---|---|---|
| CareFusion 303, Inc | UDI-DI | 2025-07-08 | Class I | Under Investigation by firm | Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. | 33,162,680 units total | |
| Becton, Dickinson & Co. | UDI-DI | 2023-10-11 | Class II | Error in labeling | Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). | ||
| Becton, Dickinson & Co. | UDI-DI | 2023-10-11 | Class II | Error in labeling | Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). | ||
| BD Switzerland Sarl | UDI-DI | 2020-04-09 | Class II | Under Investigation by firm | The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administra | 110,350 | 2020-11-02 |
| BD Switzerland Sarl | UDI-DI | 2020-04-09 | Class II | Under Investigation by firm | The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administra | 110,350 | 2020-11-02 |
| Becton, Dickinson & Co. | UDI-DI | 2019-05-06 | Class I | Nonconforming Material/Component | An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is | 17992 lots of Infusion Sets totaling 183,572,651 units (Upda | 2021-07-19 |
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.