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)

Registry build 21.09.26
49manufacturers in China registered for this device type
266catalogue 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.

Chinese manufacturers registered for FDA product code FPA
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

Regulatory record for Alaris, SmartSite
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

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 numbers for Alaris, SmartSite
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

Other products under the same FDA 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.

Recalls naming the identifiers of Alaris, SmartSite
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer