Alaris, VersaSafe
Pump Infusion Burette Set, Smallbore Tubing Split Septum Port (Burette) 3 VersaSave Split Septum Y-Sites 328 cm (129 in)
49manufacturers in China registered for this device type
64catalogue 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 | 2024-07-23 (version 8) |
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 | Storage environment temperature -40 to 125 °F |
| Packaging | Case of 20, case of 100, case of 10, case of 50, case of 72 |
| Sizes | Length 5 to 148 in |
| Distribution end date | 2024-01-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2130-0500 | Length 116 in | In distribution |
| 10014813 | Length 6 in | In distribution |
| 2131-0500 | Length 109 in | In distribution |
| 10796815 | Length 11 in | In distribution |
| 11130148 | Length 116 in | In distribution |
| 10796814 | Length 41 in | In distribution |
| 10849550 | Length 100 in | In distribution |
| 2120-0007 | Length 118 in | In distribution |
| 10807853 | Length 18 in | In distribution |
| 10796813 | Length 104 in | In distribution |
| 10807851 | Length 18 in | In distribution |
| 2107-0500 | In distribution | |
| 11147991 | Length 56 in | In distribution |
| 2121-0500 | Length 115 in | In distribution |
| 11147992 | Length 113 in | In distribution |
| 2122-0007 | Length 107 in | In distribution |
| 2171-0007 | Length 108 in | In distribution |
| 2123-0007 | Length 102 in | In distribution |
| 2110-0500 | Length 116 in | In distribution |
| 2141-0600 | Length 129 in | In distribution |
| 2126-0500 | Length 107 in | In distribution |
| 2129-0500 | Length 110 in | In distribution |
| 2126-0007 | Length 107 in | In distribution |
| 11258588 | Length 86 in | In distribution |
| 10796812 | Length 105 in | In distribution |
| 10793510 | Length 105 in | In distribution |
| 10807859 | Length 22 in | In distribution |
| 10011462 | Length 124 in | In distribution |
| 11275183 | Length 20 in | In distribution |
| 2120-0500 | Length 117 in | In distribution |
| 21001M-07 | Length 5 in | In distribution |
| 2125-0500 | Length 118 in | In distribution |
| 11202652 | Length 33 in | In distribution |
| 2929-0500 | Length 148 in | In distribution |
| 2177-0000 | Length 122 in | In distribution |
| 10807856 | Length 104 in | In distribution |
| 10779313 | Length 125 in | In distribution |
| 2111-0500 | Length 116 in | In distribution |
| 11133698 | Length 115 in | In distribution |
| 10807854 | Length 9 in | In distribution |
| 11401542 | Length 132 in | In distribution |
| 2147-0600 | Withdrawn | |
| 11501183 | Withdrawn | |
| 2140-0600 | Withdrawn | |
| 10807857 | Withdrawn | |
| 72900M | Withdrawn | |
| 41400M-07 | Withdrawn | |
| 48001M-05 | Withdrawn | |
| 41001M-07 | Withdrawn | |
| 10796811 | Withdrawn | |
| 11499817 | Withdrawn | |
| 48000M-07 | Withdrawn | |
| 11202653 | Withdrawn | |
| 11202651 | Withdrawn | |
| 41001M-05 | Withdrawn | |
| 11132982 | Withdrawn | |
| 11147994 | Withdrawn | |
| 420800E-07 | Withdrawn | |
| 41000M-07 | Withdrawn | |
| 41000M-05 | Withdrawn | |
| 31000M-05 | Withdrawn | |
| 21000M-07 | Withdrawn | |
| 2106-0500 | Withdrawn | |
| 11325479 | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 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.