Alaris, SmartSite
Gravity Burette Set, 1.2 Micron Low Protein Binding Filter Needle-Free Valve (Burette) Needle-Free Valve Ball Valve Drip Chamber Vented/Nonvented 254 cm (100 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 |
| Premarket notification | Exempt |
| Record published | 2016-09-22 |
| 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 |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -40 to 125 °F |
| Packaging | Case of 20, case of 100, case of 10, case of 50, box of 25, case of 4 |
| Sizes | Length 3.5 to 236 in |
| Distribution end date | 2023-02-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10178573 | Length 128 in | In distribution |
| 10010971 | Length 43 in | In distribution |
| 10013186 | Length 117 in | In distribution |
| 20338E | Length 8 in | In distribution |
| 2466-0007 | Length 87 in | In distribution |
| 2419-0007 | Length 148 in | In distribution |
| 2432-0007 | Length 117 in | In distribution |
| 2421-0500 | Length 117 in | In distribution |
| 31202E | Length 20 in | In distribution |
| 30202E | Length 20 in | In distribution |
| 20128E | Length 17 in | In distribution |
| 10813621 | Length 159 in | In distribution |
| 10013037 | Length 122 in | In distribution |
| C24116E | Length 117 in | In distribution |
| 2409-0500 | Length 160 in | In distribution |
| 22604-B007 | Length 118 in | In distribution |
| 10010871 | Length 69 in | In distribution |
| C24101E | Length 112 in | In distribution |
| C24105E | Length 111 in | In distribution |
| 30263E | Length 40 in | In distribution |
| 2413-0007 | Length 134 in | In distribution |
| 10010741 | In distribution | |
| 10037032 | Length 100 in | In distribution |
| 10014692 | Length 10 in | In distribution |
| 10010541-07 | Length 124 in | In distribution |
| 11607704 | In distribution | |
| 11484001 | Length 105 in | In distribution |
| 20035E | Length 6 in | In distribution |
| 47177E | Length 104 in | In distribution |
| C25002E | Length 236 in | In distribution |
| 41135E | Length 88 in | In distribution |
| 0.00421 | Length 191 in | In distribution |
| C42007E | Length 119 in | In distribution |
| 20028E | Length 17 in | In distribution |
| 20350E | Length 17 in | In distribution |
| 10016072 | Length 36 in | In distribution |
| 2411-0500 | Length 114 in | In distribution |
| 10108964 | Length 38 in | In distribution |
| 10817920 | Length 123 in | In distribution |
| 11609481 | Length 125 in | In distribution |
| 20059E | Length 7.5 in | In distribution |
| 10015488 | Length 8 in | In distribution |
| 2000EA | Size = Priming Volume = 0.1 millilitre (mL) | In distribution |
| 2451-0007 | Length 134 in | In distribution |
| 30842E | Length 13 in | In distribution |
| 10010511 | Length 6 in | In distribution |
| C25004E | Length 182 in | In distribution |
| 2450-0500 | Length 129 in | In distribution |
| 10012182 | Length 159 in | In distribution |
| 11045328 | Length 123 in | In distribution |
| 10013902 | Length 16 in | In distribution |
| 2408-0500 | Length 124 in | In distribution |
| 10015861A | Length 127 in | In distribution |
| 10015104 | Length 106 in | In distribution |
| 22401-0007 | Length 123 in | In distribution |
| 20057E | Length 8.5 in | In distribution |
| 31262E | Length 40 in | In distribution |
| 11171447 | Length 126 in | In distribution |
| 10013889 | Length 138 in | In distribution |
| 82104E | Length 100 in | In distribution |
| 10561554 | Length 126 in | In distribution |
| 30204E | Length 8 in | In distribution |
| 30262E | Length 40 in | In distribution |
| C24106E | Length 92 in | In distribution |
| 10015294 | Length 140 in | In distribution |
| C24107E | Length 91 in | In distribution |
| 2403-0007 | Length 87 in | In distribution |
| 11287205 | Length 128 in | In distribution |
| 10406194 | Length 154 in | In distribution |
| 10037031 | Length 100 in | In distribution |
| C24103E | Length 117 in | In distribution |
| 2463-0007 | Length 120 in | In distribution |
| 2477-0007 | Length 121 in | In distribution |
| 2455-0500 | Length 56 in | In distribution |
| 10927766 | Length 125 in | In distribution |
| 10012144 | Length 124 in | In distribution |
| 10015862 | Length 45 in | In distribution |
| 10074281A | Length 130 in | In distribution |
| C25013E | Length 7 in | In distribution |
| 11118122 | Length 130 in | In distribution |
| 2202E | Size = Priming Volume = 0.05 millilitre (mL) | In distribution |
| 11522558 | Length 126 in | In distribution |
| 41137E | Length 136 in | In distribution |
| 11404930 | Length 117 in | In distribution |
| 2420-0500 | Length 117 in | In distribution |
| 2424-0007 | Length 124 in | In distribution |
| 20062E | Length 7.5 in | In distribution |
| 2438-0500 | Length 128 in | In distribution |
| C24111E | Length 121 in | In distribution |
| 47233E | Length 104 in | In distribution |
| 30201E | Length 3.5 in | In distribution |
| 42490E | Length 104 in | In distribution |
| 2441-0007 | Length 130 in | In distribution |
| 2412-0500 | Length 110 in | In distribution |
| 11607787 | Length 129 in | In distribution |
| 20061E | Length 7 in | In distribution |
| 20127E | Length 18 in | In distribution |
| 10015896 | Length 125 in | In distribution |
| 42233E | Length 104 in | In distribution |
| 20053E | Size = Priming Volume = 0.4 millilitre (mL) | In distribution |
| 10015312 | Length 134 in | In distribution |
| 42163E | Length 114 in | In distribution |
| 25207E | Length 34 in | In distribution |
| 10014855A | Length 116 in | In distribution |
| 10817613 | Length 110 in | In distribution |
| 2447-0007 | Length 129 in | In distribution |
| 0.00425 | Length 132 in | In distribution |
| 10012645 | Length 122 in | In distribution |
| 2423-0007 | Length 136 in | In distribution |
| 10802688 | Length 106 in | In distribution |
| 42133E | Length 104 in | In distribution |
| 10053857 | Length 102 in | In distribution |
| 2429-0007 | Length 156 in | In distribution |
| 10137405 | Length 119 in | In distribution |
| 10013854 | Length 113 in | In distribution |
| 11582773 | Length 148 in | In distribution |
| 24600-0007 | Length 120 in | In distribution |
| 20041E | Size = Priming Volume = 0.2 millilitre (mL) | In distribution |
| 10408730 | Length 124 in | In distribution |
| 20029E | Length 10 in | In distribution |
| 2449-0600 | Length 130 in | In distribution |
| 30203E | Length 9.5 in | In distribution |
| 20043E | Size = Priming Volume = 0.4 millilitre (mL) | In distribution |
| 2462-0007 | Length 93 in | In distribution |
| 2478-0000 | Length 100 in | In distribution |
| 42433E | Length 104 in | In distribution |
| 10382963 | Length 138 in | In distribution |
| 0.0041138 | Length 136 in | In distribution |
| 11613191 | Length 130 in | In distribution |
| 2452-0007 | Length 111 in | In distribution |
| 21059E | Length 8.5 in | In distribution |
| 2448-0007 | Length 125 in | In distribution |
| 2435-0007 | Length 156 in | In distribution |
| 20159E | Length 10 in | In distribution |
| 10013361 | Length 118 in | In distribution |
| 11590099 | Length 10 in | In distribution |
| 20037E | Size = Priming Volume = 0.3 millilitre (mL) | In distribution |
| 2426-0007 | Length 126 in | In distribution |
| 10011253 | Length 8 in | In distribution |
| C25015E | In distribution | |
| 30207E | Length 17 in | In distribution |
| 2434-0007 | Length 114 in | In distribution |
| 22001E-07 | Length 24 in | In distribution |
| 11532269 | Length 125 in | In distribution |
| 2447-0600 | Length 129 in | In distribution |
| 30212E | Length 21 in | In distribution |
| 10879391 | Length 116 in | In distribution |
| 10142568 | Length 134 in | In distribution |
| 2410-0500 | Length 114 in | In distribution |
| 37262E | Size = Priming Volume = 6 millilitre (mL) | In distribution |
| 2465-0007 | Length 115 in | In distribution |
| 10061661A | Length 121 in | In distribution |
| 0.0022003 | Length 8.5 in | In distribution |
| 11426965 | Length 137 in | In distribution |
| 2416-0007 | Length 109 in | In distribution |
| 42434E | Length 104 in | In distribution |
| 2433-0007 | Length 117 in | In distribution |
| 10010454 | Length 115 in | In distribution |
| 2429-0500 | Length 110 in | In distribution |
| 42103E-07 | Length 100 in | In distribution |
| 41173E | Length 104 in | In distribution |
| 2420-0007 | Length 117 in | In distribution |
| 42274E | Length 104 in | In distribution |
| 42493E | Length 104 in | In distribution |
| 11590100 | Length 107 in | In distribution |
| C25005E | Length 144 in | In distribution |
| 10012564 | Length 104 in | In distribution |
| 10013034 | Length 128 in | In distribution |
| 10879047 | Length 117 in | In distribution |
| 2401-0500 | Length 109 in | In distribution |
| MPC-02 | In distribution | |
| 25208E | Length 34 in | In distribution |
| 20049E | Length 13 in | In distribution |
| 2406-0500 | Length 112 in | In distribution |
| 11419365 | Length 159 in | In distribution |
| 10933805 | Length 117 in | In distribution |
| 42193E-0500 | Length 104 in | In distribution |
| 41134E | Length 104 in | In distribution |
| 10013784 | Length 23 in | In distribution |
| 2444-0007 | Length 123 in | In distribution |
| 20021E | Size = Priming Volume = 0.2 millilitre (mL) | In distribution |
| 2443-0600 | Length 131 in | In distribution |
| 20039E | Length 6 in | In distribution |
| 2440-0500 | Length 153 in | In distribution |
| 10321213 | Length 106 in | In distribution |
| 2414-0500 | Size = Priming Volume = 24 millilitre (mL) | In distribution |
| 22059E | Length 9 in | In distribution |
| 21028E | Length 18 in | In distribution |
| 20038E | Length 4.6 in | In distribution |
| 25202E | Length 37 in | In distribution |
| 10073124 | Length 110 in | In distribution |
| 42933E | Length 104 in | In distribution |
| 2441-0600 | Length 129 in | In distribution |
| 10015012 | Length 125 in | In distribution |
| 2422-0007 | Length 158 in | In distribution |
| 20060E | In distribution | |
| 2426-0500 | Length 126 in | In distribution |
| 20519E | Length 43 in | In distribution |
| 10010983 | Length 8.5 in | In distribution |
| 24001-0007 | Length 47 in | In distribution |
| 20337E | Length 7.5 in | In distribution |
| 2428-0007 | Length 127 in | In distribution |
| 10031773 | Length 140 in | In distribution |
| 11619427 | In distribution | |
| 10013072 | Length 103 in | In distribution |
| 20019E | Size = Priming Volume = 0.4 millilitre (mL) | In distribution |
| 10010453 | Length 114 in | In distribution |
| 2461-0007 | Length 137 in | In distribution |
| 11063735-07 | Length 125 in | In distribution |
| 10015489 | Length 126 in | In distribution |
| 2450-0007 | Length 144 in | In distribution |
| 42401E-07 | In distribution | |
| 20511E | Length 45 in | In distribution |
| 10404198 | Length 153 in | In distribution |
| 10015171 | Length 104 in | In distribution |
| 42522E-07 | In distribution | |
| 2425-0500 | Length 117 in | In distribution |
| 11059729 | Length 130 in | In distribution |
| 24008-0007 | Length 130 in | In distribution |
| 30920-07 | Length 60 in | In distribution |
| 10015645 | Length 116 in | In distribution |
| 10406890 | Length 110 in | In distribution |
| 2000E | In distribution | |
| 10012283 | Length 130 in | In distribution |
| C24104E | Length 152 in | In distribution |
| 10010912 | Length 9 in | In distribution |
| 10821753 | Length 126 in | In distribution |
| 20051E | Size = Priming Volume = 0.2 millilitre (mL) | In distribution |
| 20101E-07 | Withdrawn | |
| 22008E-07 | Withdrawn | |
| 10934345 | Withdrawn | |
| 10010833 | Withdrawn | |
| 32400E-07 | Withdrawn | |
| 82105E | Withdrawn | |
| 41136E | Withdrawn | |
| 30206E-05 | Withdrawn | |
| 10012802 | Withdrawn | |
| 42408E-07 | Withdrawn | |
| 2448-0600 | Withdrawn | |
| 10010547 | Withdrawn | |
| 20100E | Withdrawn | |
| 42506E-07 | Withdrawn | |
| 72023KE | Withdrawn | |
| 42404E-07 | Withdrawn | |
| 42105E-05 | Withdrawn | |
| 20102E-07 | Withdrawn | |
| 30059E | Withdrawn | |
| 22009E-07 | Withdrawn | |
| 30049E | Withdrawn | |
| 2403-0000 | Withdrawn |
Showing 250 of 266 catalogue numbers.
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 |
| 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 |
| Alaris | BD Switzerland Sàrl | 122 |
Showing 12 of 768. All products under Set, Administration, Intravascular
Recalls Naming This Product
7 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 | 2025-09-11 | 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. | ||
| 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 | |
| BD Switzerland Sarl | UDI-DI | 2024-04-18 | Class II | Process control | Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates. | 11.300 sets | |
| 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). | ||
| Carefusion | UDI-DI | 2021-08-02 | Class II | Process control | Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required | 1,463,647 | |
| 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.