Extension Set
Small bore extension set with non-removable slide clamp and SPIN-LOCK® connector with priming volume: 0.5 mL. Length 17 in. (43 cm)
49manufacturers in China registered for this device type
171catalogue 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 |
| Premarket notification | Exempt |
| Record published | 2023-07-13 |
| Record revised | 2023-06-20 (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 | 2024-10-10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 490648 | 50 | In distribution | |
| 490462 | 50 | In distribution | |
| 490113 | 50 | In distribution | |
| 456030 | 50 | In distribution | |
| 490541 | 50 | In distribution | |
| 490443 | 50 | In distribution | |
| 490396 | 50 | In distribution | |
| 477014 | 50 | In distribution | |
| 490515 | 50 | In distribution | |
| 470166 | 50 | In distribution | |
| 456524 | 50 | In distribution | |
| V6222 | 50 | In distribution | |
| 477037 | 50 | In distribution | |
| 471950 | 100 | In distribution | |
| 473210 | 100 | In distribution | |
| 490459 | 50 | In distribution | |
| 470153 | 50 | In distribution | |
| 354222 | 100 | In distribution | |
| V6220 | 50 | In distribution | |
| 473054 | 100 | In distribution | |
| 477040 | 50 | In distribution | |
| 490538 | 50 | In distribution | |
| 456520 | 50 | In distribution | |
| V5484 | 50 | In distribution | |
| 470170 | 50 | In distribution | |
| 477045 | 50 | In distribution | |
| 490514 | 50 | In distribution | |
| 470073 | 50 | In distribution | |
| 470058 | 50 | In distribution | |
| V6215 | 50 | In distribution | |
| 490534 | 50 | In distribution | |
| 477038 | 50 | In distribution | |
| 490465 | 50 | In distribution | |
| 471973 | 100 | In distribution | |
| 490234 | 24 | In distribution | |
| 490512 | 50 | In distribution | |
| 490495 | 50 | In distribution | |
| 490539 | 50 | In distribution | |
| 477015 | 50 | In distribution | |
| 477039 | 50 | In distribution | |
| 474920 | 50 | In distribution | |
| 470195 | 50 | In distribution | |
| 477016 | 50 | In distribution | |
| 456526 | 50 | In distribution | |
| 480225 | 50 | In distribution | |
| 490447 | 50 | In distribution | |
| 470151 | 50 | In distribution | |
| 471962 | 100 | In distribution | |
| 477050 | 24 | In distribution | |
| 471979 | 100 | In distribution | |
| 471949 | 100 | In distribution | |
| 473335 | 50 | In distribution | |
| 480223 | 50 | In distribution | |
| 351410 | 10 | In distribution | |
| 470159 | 100 | In distribution | |
| 480226 | 50 | In distribution | |
| 490579 | 24 | In distribution | |
| 490478 | 24 | In distribution | |
| 490494 | 50 | In distribution | |
| 470169 | 50 | In distribution | |
| 471959 | 100 | In distribution | |
| 490445 | 50 | In distribution | |
| 490269 | 50 | In distribution | |
| 471980 | 50 | In distribution | |
| 490630 | 50 | In distribution | |
| 474912 | 50 | In distribution | |
| 473009 | 100 | In distribution | |
| 470180 | 24 | In distribution | |
| 473543 | 50 | In distribution | |
| 490204 | 50 | In distribution | |
| 490335 | 50 | In distribution | |
| 480203 | 50 | In distribution | |
| 490516 | 50 | In distribution | |
| 470072 | 50 | In distribution | |
| 470163 | 50 | In distribution | |
| 477052 | 50 | In distribution | |
| 473541 | 50 | In distribution | |
| 470125 | 50 | In distribution | |
| 477018 | 50 | In distribution | |
| 470197 | 50 | In distribution | |
| 490591 | 50 | In distribution | |
| 470150 | 50 | In distribution | |
| 490604 | 24 | In distribution | |
| 470164 | 50 | In distribution | |
| 490419 | 50 | In distribution | |
| 490650 | 50 | In distribution | |
| 471954 | 100 | In distribution | |
| 490540 | 50 | In distribution | |
| 490533 | 50 | In distribution | |
| 480206 | 50 | In distribution | |
| 470029 | 50 | In distribution | |
| 490464 | 50 | In distribution | |
| 477033 | 50 | In distribution | |
| 471957 | 100 | In distribution | |
| 490461 | 50 | In distribution | |
| 470023 | 50 | In distribution | |
| 490433 | 50 | In distribution | |
| 470065 | 100 | In distribution | |
| 490628 | 24 | In distribution | |
| 490291 | 50 | In distribution | |
| 490056 | 50 | In distribution | |
| 490603 | 24 | In distribution | |
| V5406 | 50 | In distribution | |
| 490593 | 50 | In distribution | |
| 474905 | 50 | In distribution | |
| 471975 | 100 | In distribution | |
| 490466 | 50 | In distribution | |
| 456522 | 50 | In distribution | |
| 470172 | 100 | In distribution | |
| 490556 | 24 | In distribution | |
| 470060 | 50 | In distribution | |
| 490496 | 50 | In distribution | |
| 457505 | 100 | In distribution | |
| V6203 | 50 | In distribution | |
| 470131 | 50 | In distribution | |
| V6223 | 50 | In distribution | |
| 490536 | 50 | In distribution | |
| 473012 | 100 | In distribution | |
| 490439 | 50 | In distribution | |
| 473309 | 50 | In distribution | |
| 490203 | 50 | In distribution | |
| V5450 | 50 | In distribution | |
| 490449 | 50 | In distribution | |
| 490622 | 24 | In distribution | |
| 471991 | 100 | In distribution | |
| 473007 | 100 | In distribution | |
| 490139 | 50 | In distribution | |
| 490524 | 24 | In distribution | |
| 472036 | 50 | In distribution | |
| 490316 | 50 | In distribution | |
| 473041 | 100 | In distribution | |
| 490458 | 50 | In distribution | |
| 490238 | 50 | In distribution | |
| 473105 | 100 | In distribution | |
| 470064 | 50 | In distribution | |
| 471953 | 100 | In distribution | |
| 490493 | 50 | In distribution | |
| 490577 | 24 | In distribution | |
| 477010 | 50 | In distribution | |
| 456508 | 50 | In distribution | |
| V5456 | 50 | In distribution | |
| 477011 | 50 | In distribution | |
| 490621 | 24 | In distribution | |
| 480205 | 50 | In distribution | |
| 490318 | 50 | In distribution | |
| 490448 | 50 | In distribution | |
| 470167 | 50 | In distribution | |
| 490624 | 50 | In distribution | |
| 490486 | 24 | In distribution | |
| 471960 | 100 | In distribution | |
| 490094 | 50 | Withdrawn | |
| V5409 | 50 | Withdrawn | |
| 473328 | 50 | Withdrawn | |
| V5402 | 50 | Withdrawn | |
| 474577 | 50 | Withdrawn | |
| 490463 | 50 | Withdrawn | |
| 490440 | 50 | Withdrawn | |
| 470198 | 50 | Withdrawn | |
| 490047 | 50 | Withdrawn | |
| 490083 | 50 | Withdrawn | |
| 480227 | 50 | Withdrawn | |
| 477034 | 50 | Withdrawn | |
| 456505 | 100 | Withdrawn | |
| V5405 | 50 | Withdrawn | |
| 470061 | 50 | Withdrawn | |
| 473303 | 50 | Withdrawn | |
| 473022 | 100 | Withdrawn | |
| V5424 | 50 | Withdrawn | |
| 490480 | 24 | Withdrawn | |
| 480244 | 50 | Withdrawn | |
| 490164 | 50 | 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 |
| MaxGuard | BD Switzerland Sàrl | 150 |
| Medline | Medline Industries, Inc. | 148 |
| Centurion | Centurion Medical Products Corporation | 145 |
| Alaris | BD Switzerland Sàrl | 122 |
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
12 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). | 11,650 units |
| 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). | 30,250 units |
| 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). | 2,100 units |
| 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). | 43,452 units |
| 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). | 23,650 units |
| 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). | 27,480 units |
| 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). | 11,800 units |
| 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). | 61,423 units |
| 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). | 300 units |
| B. Braun Medical Inc. | UDI-DI | 2025-07-09 | Class I | Process control | Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to | 34,825 units US |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-08-08 | Class II | Process change control | Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process. | 19050 units |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2022-09-15 | Class II | Process design | The extension set has a high probability of failure which could lead to possible leakage or detachment at the device’s bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and ma | 354,200 US; 1,800 OUS |
Recalls
36 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). | 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). | 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). | 49,330,370 |
| 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). | 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.