BD SmartSite
Syringe Administration Set, Microbore Tubing segments, 0.2 Micron Low Protein Binding Filter, Check Valve, Anti-siphon Valve, Needle-Free Valve, Pressure Sensing Disk, Vented/Nonvented, 244…
Syringe Administration Set, Microbore Tubing segments, 0.2 Micron Low Protein Binding Filter, Check Valve, Anti-siphon Valve, Needle-Free Valve, Pressure Sensing Disk, Vented/Nonvented, 244 cm (96 in)
49manufacturers in China registered for this device type
39catalogue 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 |
| Record published | 2016-09-22 |
| Record revised | 2025-08-01 (version 9) |
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 |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Keep dry; Special storage condition: Storage Temperature; Storage environment temperature -40 to 125 °F; Special storage condition: Fragile, handle with care |
| Packaging | Case of 20, case of 50, case of 100, case of 4, box of 25 |
| Sizes | Length 4 to 148 in; length 10 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42518E-05 | Size = Priming Volume = 23 millilitre (mL) | In distribution |
| 10798696 | Size = Priming Volume = 11 millilitre (mL) | In distribution |
| 42405E-07 | Size = Priming Volume = 26 millilitre (mL) | In distribution |
| 42081E | Size = Priming Volume = 30 millilitre (mL) | In distribution |
| C42006E | Size = Priming Volume = 22 millilitre (mL) | In distribution |
| 82113E | Length 22 in | In distribution |
| 70001B-07T | Size = Priming Volume = 12 millilitre (mL) | In distribution |
| 42082E | Size = Priming Volume = 29 millilitre (mL) | In distribution |
| 10013364 | Size = Priming Volume = 7 millilitre (mL) | In distribution |
| C42010E | Size = Priming Volume = 25 millilitre (mL) | In distribution |
| 42407E-05 | Size = Priming Volume = 26 millilitre (mL) | In distribution |
| 4030B-07T | Size = Priming Volume = 14 millilitre (mL) | In distribution |
| 11059728 | Size = Priming Volume = 20 millilitre (mL) | In distribution |
| C42014E-07 | Size = Priming Volume = 24 millilitre (mL) | In distribution |
| 10689602 | Size = Priming Volume = 13 millilitre (mL) | In distribution |
| 2519A | Size = Priming Volume = 1.5 millilitre (mL) | In distribution |
| 82114E | Length 24 in | In distribution |
| 42519E | Size = Priming Volume = 22 millilitre (mL) | In distribution |
| 10014881 | Size = Priming Volume = 11 millilitre (mL) | In distribution |
| 42511E | Size = Priming Volume = 21 millilitre (mL) | In distribution |
| 82115E | Size = Priming Volume = 30 millilitre (mL) | In distribution |
| 10010903 | Size = Priming Volume = 67 millilitre (mL) | In distribution |
| 2309E | Size = Priming Volume = 0.9 millilitre (mL) | In distribution |
| 42521E | Size = Priming Volume = 28 millilitre (mL) | In distribution |
| 11059727 | Size = Priming Volume = 20 millilitre (mL) | In distribution |
| 30843E | Size = Priming Volume = 1 millilitre (mL) | In distribution |
| CS42522E-07 | Size = Priming Volume = 30 millilitre (mL) | In distribution |
| 2300E-0500 | Size = Priming Volume = 0.5 millilitre (mL) | In distribution |
| 10050187 | Size = Priming Volume = 12 millilitre (mL) | In distribution |
| 10013365 | Size = Priming Volume = 0.6 millilitre (mL) | In distribution |
| 30916-07 | Size = Priming Volume = 0.8 millilitre (mL) | In distribution |
| 10425228 | Size = Priming Volume = 19 millilitre (mL) | In distribution |
| 42504E | Size = Priming Volume = 20 millilitre (mL) | In distribution |
| C42016E-07 | Length 145 in | In distribution |
| C42013E | Size = Priming Volume = 21 millilitre (mL) | In distribution |
| 10011265 | Size = Priming Volume = 20 millilitre (mL) | In distribution |
| 42503E | Size = Priming Volume = 18 millilitre (mL) | In distribution |
| 10050186 | Size = Priming Volume = 12 millilitre (mL) | In distribution |
| 42502E | Size = Priming Volume = 21 millilitre (mL) | In distribution |
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
3 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 |
|---|---|---|---|---|---|---|---|
| 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). | ||
| Becton, Dickinson & Co. | UDI-DI | 2019-02-28 | Class I | Process control | Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates. | 2900 Sets | 2020-07-30 |
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.