Vygon
40" Standardbore AD-MIX SET With Pinch Clamp, Vented Spike, AND Dual Check Valve With Male/Female Luer Locks
49manufacturers in China registered for this device type
355catalogue numbers in this listing
2510(k) clearances naming this product 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 | Vygon Corp., United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| 510(k) | K013949 |
| Record published | 2020-01-28 |
| Record revised | 2020-07-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 40 °C |
| Packaging | Pack of 50, pack of 12, pack of 100, pack of 18, pack of 21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BN-300 | In distribution | |
| BN-443 | In distribution | |
| AMS-451 | In distribution | |
| AMS-596-2 | In distribution | |
| KS-222-2 | In distribution | |
| AMS-945 | In distribution | |
| CLG-1910 | In distribution | |
| KS-222-2 | In distribution | |
| BN-602 | In distribution | |
| AMS-747 | In distribution | |
| SHY-2234 | In distribution | |
| CLG-2010 | In distribution | |
| SS-761B | In distribution | |
| BN-396 | In distribution | |
| AMS-428 | In distribution | |
| AMS-391 | In distribution | |
| SHS-2210-1 | In distribution | |
| AMS-588 | In distribution | |
| AMS-895C | In distribution | |
| SHS-2250 | In distribution | |
| BN-3082CV | In distribution | |
| SS-761B | In distribution | |
| AMS-836 | In distribution | |
| KS-975NF-2 | In distribution | |
| AMS-887-4 | In distribution | |
| CLGY-2034-1 | In distribution | |
| CLG-2010 | In distribution | |
| AMS-900CV | In distribution | |
| AMS-2001 | In distribution | |
| VYCIS001 | In distribution | |
| AMS-887-4 | In distribution | |
| AMS-467 | In distribution | |
| FI-2075 | In distribution | |
| AMS-638A | In distribution | |
| AMS-887-4 | In distribution | |
| BN-140 | In distribution | |
| VYCIS009 | In distribution | |
| CLG-2250 | In distribution | |
| AMS-290 | In distribution | |
| AMS-952-1 | In distribution | |
| BN-443 | In distribution | |
| AMS-879-2 | In distribution | |
| AMS-483C | In distribution | |
| AMS-485-2 | In distribution | |
| SHY-2015 | In distribution | |
| AMS-410 | In distribution | |
| AMS-541 | In distribution | |
| CLG-2234 | In distribution | |
| SHY-2034-1 | In distribution | |
| KS-122-2 | In distribution | |
| AMS-1200 | In distribution | |
| AMS-944 | In distribution | |
| BN-441 | In distribution | |
| CMS-5000 | In distribution | |
| AMS-588 | In distribution | |
| AMS-516 | In distribution | |
| CLG-2234-1 | In distribution | |
| CLG-1934 | In distribution | |
| VYCIS004 | In distribution | |
| BN-140 | In distribution | |
| AMS-637B | In distribution | |
| CLG-1910-1 | In distribution | |
| PPS-2275 | In distribution | |
| CMS-808-1 | In distribution | |
| AMS-436 | In distribution | |
| AMS-761 | In distribution | |
| AMS-975NF | In distribution | |
| CLG-2010-1 | In distribution | |
| BN-160 | In distribution | |
| CMS-809-2 | In distribution | |
| 0000-9752-01 | In distribution | |
| 246.06 | In distribution | |
| CLGY-1910 | In distribution | |
| CMS-862 | In distribution | |
| AMS-761NS | In distribution | |
| AMS-541 | In distribution | |
| AMS-391 | In distribution | |
| AMS-295-1 | In distribution | |
| CLGY-2010 | In distribution | |
| CLGY-2050 | In distribution | |
| SS-933-1 | In distribution | |
| AMS-803 | In distribution | |
| AMS-500 | In distribution | |
| CLGY-2010 | In distribution | |
| AMS-664-2 | In distribution | |
| VYCIS012 | In distribution | |
| AMS-441 | In distribution | |
| CLG-2250 | In distribution | |
| AMS-435CV-1 | In distribution | |
| AMS-2000 | In distribution | |
| SHS-2234 | In distribution | |
| 246.052 | In distribution | |
| AMS-485-2 | In distribution | |
| AMS-895C | In distribution | |
| AMS-546-2 | In distribution | |
| KS-122-2 | In distribution | |
| CLG-2210 | In distribution | |
| AMS-975-1 | In distribution | |
| BN-150 | In distribution | |
| AMS-437 | In distribution | |
| AMS-934-1 | In distribution | |
| AMS-975-1 | In distribution | |
| AMS-375-1 | In distribution | |
| SS-885-2 | In distribution | |
| AMS-892C | In distribution | |
| AMS-500 | In distribution | |
| AMS-673 | In distribution | |
| AMS-530 | In distribution | |
| CLGY-2015 | In distribution | |
| BN-300 | In distribution | |
| AMS-428 | In distribution | |
| AMS-819 | In distribution | |
| AMS-516 | In distribution | |
| KS-975-2 | In distribution | |
| AMS-934-1 | In distribution | |
| SHY-2010-1 | In distribution | |
| AMS-884-2T | In distribution | |
| AMS-122-1 | In distribution | |
| BN-300NS | In distribution | |
| AMS-903-1MNV | In distribution | |
| AMS-636 | In distribution | |
| CMS-809-1 | In distribution | |
| AMS-819 | In distribution | |
| AMS-436 | In distribution | |
| AMS-894ML | In distribution | |
| AMS-893 | In distribution | |
| AMS-295-1 | In distribution | |
| AMS-437 | In distribution | |
| BN-208 | In distribution | |
| AMS-635CV-1 | In distribution | |
| CMS-809 | In distribution | |
| BN-208 | In distribution | |
| AMS-550 | In distribution | |
| SHY-2234 | In distribution | |
| AMS-900CV | In distribution | |
| CMS-02 | In distribution | |
| AMS-483C | In distribution | |
| 1VTUSBN-448 | In distribution | |
| AMS-577-2 | In distribution | |
| CLG-2034 | In distribution | |
| CLG-2034-1 | In distribution | |
| AMS-532 | In distribution | |
| SHS-2034 | In distribution | |
| SS-933-1 | In distribution | |
| SSP-395 | In distribution | |
| AMS-2001 | In distribution | |
| KS-975NF-2 | In distribution | |
| SHS-2034 | In distribution | |
| AMS-2000 | In distribution | |
| AMS-530 | In distribution | |
| SHY-2010 | In distribution | |
| AMS-441 | In distribution | |
| AMS-636 | In distribution | |
| CMS-03 | In distribution | |
| VYCIS002 | In distribution | |
| PPS-2075 | In distribution | |
| CLG-2210 | In distribution | |
| AMS-283 | In distribution | |
| BN-4678 | In distribution | |
| BN-602 | In distribution | |
| CMS-807-1 | In distribution | |
| VYCIS011 | In distribution | |
| AMS-1200 | In distribution | |
| CLG-1910 | In distribution | |
| AMS-892C | In distribution | |
| AMS-520 | In distribution | |
| AMS-945 | In distribution | |
| BN-448 | In distribution | |
| AMS-530 | In distribution | |
| AMS-570 | In distribution | |
| SS-761B | In distribution | |
| CLG-2015 | In distribution | |
| CMS-807-1 | In distribution | |
| AMS-672 | In distribution | |
| AMS-899-G | In distribution | |
| AMS-451 | In distribution | |
| CLGY-2250 | In distribution | |
| SHS-2010 | In distribution | |
| BN-448 | In distribution | |
| BN-448 | In distribution | |
| AMS-1200 | In distribution | |
| SHY-2210 | In distribution | |
| AMS-401 | In distribution | |
| CLGY-2034 | In distribution | |
| CLGY-1910 | In distribution | |
| AMS-620FC | In distribution | |
| SHS-2210 | In distribution | |
| AMS-975NF | In distribution | |
| BN-3083CV | In distribution | |
| BN-762 | In distribution | |
| AMS-391 | In distribution | |
| SHY-2250 | In distribution | |
| AMS-597 | In distribution | |
| AMS-636 | In distribution | |
| CLG-2250-1 | In distribution | |
| AMS-638A | In distribution | |
| SHS-1910 | In distribution | |
| BN-450 | In distribution | |
| SHS-2034-1 | In distribution | |
| AMS-597 | In distribution | |
| AMS-899-G | In distribution | |
| SHS-2015 | In distribution | |
| KS-975-2 | In distribution | |
| BN-308 | In distribution | |
| BN-396 | In distribution | |
| AMS-516 | In distribution | |
| AMS-945 | In distribution | |
| SHY-2034 | In distribution | |
| AMS-290 | In distribution | |
| CLGY-2015 | In distribution | |
| AMS-385 | In distribution | |
| AMS-761 | In distribution | |
| AMS-900CV | In distribution | |
| SS-885-2 | In distribution | |
| SHY-1910 | In distribution | |
| CLGY-1934 | In distribution | |
| CLGY-2015-1 | In distribution | |
| SHS-2210 | In distribution | |
| BN-762 | In distribution | |
| AMS-893 | In distribution | |
| SSP-395 | In distribution | |
| AMS-435CV-1 | In distribution | |
| AMS-761 | In distribution | |
| 246.05 | In distribution | |
| CLGY-2010-1 | In distribution | |
| AMS-540-1 | In distribution | |
| AMS-884-2T | In distribution | |
| CLG-2210-1 | In distribution | |
| AMS-1200LRM | In distribution | |
| AMS-500 | In distribution | |
| AMS-435CV-1 | In distribution | |
| VYCIS005 | In distribution | |
| AMS-934-1 | In distribution | |
| AMS-283 | In distribution | |
| CLG-1934-1 | In distribution | |
| AMS-588 | In distribution | |
| 0000-9752-01 | In distribution | |
| AMS-519-1 | In distribution | |
| BN-441 | In distribution | |
| AMS-636NS | In distribution | |
| AMS-467C | In distribution | |
| AMS-467C | In distribution | |
| AMS-836 | In distribution | |
| KS-552 | In distribution | |
| CLG-1934 | In distribution | |
| AMS-761 | In distribution | |
| CLGY-2234 | In distribution | |
| AMS-410 | In distribution | |
| CLG-2050 | In distribution | |
| SS-885-2 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 529 |
| Codan | Codan US Corp. | 510 |
| 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 |
| Alaris | BD Switzerland Sàrl | 122 |
Showing 12 of 768. All products under Set, Administration, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K963981 | 1997-02-14 |
| K883612 | 1988-09-29 |
Recalls Naming This Product
36 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| BD Switzerland Sarl | 510(k) number | 2025-05-12 | Class II | Process control | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, tre | 2,024,780 | |
| BD Switzerland Sarl | 510(k) number | 2025-05-12 | Class II | Process control | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, tre | 1,655,300 | |
| Vygon MFG | 510(k) number | 2017-07-24 | Class II | Under Investigation by firm | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing g | 396 units | 2019-11-07 |
| Vygon MFG | 510(k) number | 2017-02-20 | Class II | Error in labeling | Incorrect priming volume printed on the device package. | 30,700 | 2019-04-22 |
| Vygon MFG | 510(k) number | 2016-11-18 | Class II | Device Design | Incorrect priming volume is printed on the device package. | 31,500 | 2017-10-23 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 5,200 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 100 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 2350 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 2200 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 450 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 0 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 129,500 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 6850 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 6850 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 1050 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 2650 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2015-01-15 | Class II | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. | 1650 | 2016-02-25 |
| Vygon MFG | 510(k) number | 2014-01-07 | Class II | Nonconforming Material/Component | Defective component may cause extension sets to leak. | 3850 | 2014-11-03 |
| Vygon MFG | 510(k) number | 2013-08-12 | Class II | Under Investigation by firm | Microbore tubing disconnecting from male luers on the extension sets. | 13100 | 2014-06-16 |
| Vygon MFG | 510(k) number | 2013-08-12 | Class II | Under Investigation by firm | Microbore tubing disconnecting from male luers on the extension sets. | 3040 | 2014-06-16 |
| Vygon MFG | 510(k) number | 2013-01-21 | Class II | Under Investigation by firm | The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set. | 2340 | 2013-09-10 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 7450 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 12150 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 2950 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 18950 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 3,000 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 3950 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 1,000 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 72 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 3,000 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 100 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 19, 750 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 5,000 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2010-11-16 | Not classified | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | 1380 units | 2012-05-01 |
| Vygon MFG | 510(k) number | 2009-10-20 | Not classified | Process change control | Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents | 283,900 each | 2013-03-28 |
| CareFusion 303, Inc | 510(k) number | 2007-08-30 | Not classified | Finished device change control | Leaks: there is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or o | 76, 300 units | 2012-03-28 |
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.