Infusomat®
(15 drops/mL) Universal spike, pinch clamp, pressure limited check valve, four CARESITE® injection sites, 92 in., 61 in., 41 in.,6 in. above distal end, free flow protection clamp,…
(15 drops/mL) Universal spike, pinch clamp, pressure limited check valve, four CARESITE® injection sites, 92 in., 61 in., 41 in.,6 in. above distal end, free flow protection clamp, backcheck valve, roller clamp, slide clamp, SPIN-LOCK® connector.
49manufacturers in China registered for this device type
74catalogue numbers in this listing
22510(k) clearances naming this product code
40recalls on this code
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 | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2026-07-16 (version 7) |
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 |
| Distribution end date | 2026-01-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 363902 | 24 | In distribution | |
| 363033 | 24 | In distribution | |
| 362035 | 24 | In distribution | |
| 362043 | 24 | In distribution | |
| 362050 | 24 | In distribution | |
| 480258 | 24 | In distribution | |
| 363419 | 24 | In distribution | |
| 363410 | 24 | In distribution | |
| 363230 | 24 | In distribution | |
| 363910 | 24 | In distribution | |
| 363422 | 20 | In distribution | |
| 490035 | 24 | In distribution | |
| 362004 | 24 | In distribution | |
| 490656 | 24 | In distribution | |
| 480255 | 24 | In distribution | |
| 490036 | 24 | In distribution | |
| 470119 | 24 | In distribution | |
| 362032 | 24 | In distribution | |
| 490100 | 24 | In distribution | |
| 490101 | 20 | In distribution | |
| 490103 | 24 | In distribution | |
| 490041 | 24 | In distribution | |
| 362432 | 24 | In distribution | |
| 490102 | 24 | In distribution | |
| 362034 | 20 | In distribution | |
| 490030 | 24 | In distribution | |
| 490104 | 24 | In distribution | |
| 363430 | 24 | In distribution | |
| 363231 | 24 | In distribution | |
| 363901 | 24 | In distribution | |
| 363210 | 24 | In distribution | |
| 490040 | 24 | In distribution | |
| 363433 | 24 | In distribution | |
| 490038 | 24 | In distribution | |
| 362431 | 24 | In distribution | |
| 363021 | 24 | In distribution | |
| 480256 | 24 | In distribution | |
| 363424 | 24 | In distribution | |
| 362420 | 24 | In distribution | |
| 363019 | 24 | In distribution | |
| 480264 | 24 | In distribution | |
| 363423 | 24 | In distribution | |
| 363421 | 24 | In distribution | |
| 363010 | 20 | In distribution | |
| 362911 | 24 | In distribution | |
| 490037 | 24 | In distribution | |
| 490105 | 24 | In distribution | |
| 363411 | 24 | In distribution | |
| 480263 | 24 | In distribution | |
| 480254 | 24 | In distribution | |
| 363032 | 20 | In distribution | |
| 363220 | 24 | In distribution | |
| 363904 | 24 | In distribution | |
| 490655 | 24 | In distribution | |
| 363420 | 24 | In distribution | |
| 480257 | 24 | In distribution | |
| 490032 | 24 | In distribution | |
| 490031 | 24 | In distribution | |
| 362033 | 24 | In distribution | |
| 363030 | 24 | In distribution | |
| 363224 | 24 | Withdrawn | |
| 490043 | 24 | Withdrawn | |
| 490034 | 20 | Withdrawn | |
| 490033 | 24 | Withdrawn | |
| 363223 | 24 | Withdrawn | |
| 362044 | 20 | Withdrawn | |
| 490042 | 24 | Withdrawn | |
| 363221 | 24 | Withdrawn | |
| 363120 | 24 | Withdrawn | |
| 363222 | 20 | Withdrawn | |
| 363431 | 24 | Withdrawn | |
| 363232 | 24 | Withdrawn | |
| 362042 | 24 | Withdrawn | |
| 363219 | 24 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243392 | 2025-07-24 |
| K213778 | 2022-03-03 |
| K212842 | 2022-01-18 |
| K202618 | 2021-09-24 |
| K191658 | 2020-03-19 |
| K173361 | 2018-06-26 |
| K170595 | 2017-11-07 |
| K153293 | 2016-04-06 |
| K143082 | 2015-07-24 |
| K140838 | 2014-12-05 |
| K142036 | 2014-08-25 |
| K140311 | 2014-05-07 |
| K112636 | 2011-11-26 |
| K083723 | 2009-06-05 |
| K073396 | 2008-08-07 |
| K052252 | 2005-11-16 |
| K041490 | 2004-10-29 |
| K031923 | 2003-08-11 |
| K021488 | 2002-07-08 |
| K974145 | 1998-01-06 |
| K955585 | 1996-05-15 |
| K954123 | 1995-11-21 |
Recalls Naming This Product
27 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| B. Braun Medical Inc. | UDI-DI | 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 49,330,370 |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 1 unit |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 47370 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 280 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 3624 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 431999 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 1152 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 2160 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 100 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 37776 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 68205 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 1325700 |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 7360 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 22560 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 32752 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 2085606 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 42028 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 109464 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 1872 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 13464 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 6843513 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 33065 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 5672116 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 643608 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 59811 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-06-17 | Class II | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and | 158904 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2023-11-01 | Class I | Process control | In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medi | 33,820,976 units |
Recalls
39 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-08-04 | Class II | Under Investigation by firm | Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label. | 25850 |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 0 |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 11,832 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 27,480 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 19,320 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 12,320 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 13,600 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 65,904 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 162,648 untis |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 12,700 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 18,984 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 1,861,111 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 960 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 80,650 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 6,768 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 48,672 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 100 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 66,792 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 29,900 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 259,392 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 286,400 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 164,568 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 40,992 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 74,652 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 19,392 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 5,448 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 11,650 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 381,850 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 43,452 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 554,015 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 190,625 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 37,656 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 88,200 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 6,672 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 30,250 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 98,568 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 28,344 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 41,400 units |
| 2025-10-29 | Class II | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | 19,104 units |
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.