BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vygon MFG

    Reg #: 1223004 · FEI: 1000120555 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    495
    Establishment Types
    5
    Classifications
    35

    Registration Details

    Registration Name
    Vygon MFG
    Registration Number
    1223004
    FEI Number
    1000120555
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    87 Venture Dr
    City
    DOVER
    State
    NH
    ZIP
    03820
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212370

    Owner / Operator

    Firm Name
    VYGON USA
    Operator Number
    2245270
    Address
    2750 Morris Road, Suite A200
    City
    Lansdale
    State
    PA
    Postal Code
    19446
    Country
    US
    Correspondent
    Chris Steinke

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Bone Marrow Biopsy Tray PXO
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Introducer, Catheter DYB
    Needle, Hypodermic, Single Lumen FMI
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Tubes, Gastrointestinal (And Accessories) KNT
    Tube, Feeding FPD
    Catheter Introducer Kit OFC
    Midline Catheter PND
    Dressing Change Tray OXQ
    Percutaneous Atrial Catheter Kit OFK
    Nerve Block Tray OGJ
    Stopcock, I.V. Set FMG
    Tubing, Fluid Delivery FPK
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Port Introducer Kit OKE
    Device, Intravascular Catheter Securement KMK
    Wire, Guide, Catheter DQX
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Percutaneous Introducer Kit PXB
    Filter, Infusion Line FPB
    Arterial Blood Sampling Kit CBT
    Container, I.V. KPE
    Intravenous Extension Tubing Set OJA
    I.V. Start Kit LRS
    Suture Removal Kit MCZ
    Scissors, Medical, Disposable JOK
    Catheters, Suction, Tracheobronchial BSY
    Circumcision Tray OHG
    Suture Kit OVN
    Spinal Epidural Anesthesia Kit OFT
    Peripheral Catheter Insertion Kit OWL
    Set, I.V. Fluid Transfer LHI
    Kit, Surgical Instrument, Disposable KDD

    Proprietary Names

    T100-000F IV Set T090-000 IV Set T030-000 IV Set T095-120 IV Set T100-000WF IV Set T100-120F IV Set T100-022F IV Set T090-022V IV Set T090-022W IV Set T100-000VF IV Set T105-000WC Set T090-000V IV Set T090-000W IV Set T095-022 IV Set Bone Marrow Procedure Tray AMS-9008 AMS-547 VYLFN1002 VYLFM1004 VYLFM1003 VYLFN1004 VYLFM1002 VYLFN1003 VIS-1045 VIS-1055 VAT MSY-2234 MSY-2250 MBS-1910 MSY-1910 MSY-2034 MBS-2234 MSY-2010 MBS-2034 MBS-2010 MBS-2015 MBS-2210 Non-coring Huber Set MBS-2210-1 MSY-2010-1 MSY-2034-1 MBS-2034-1 MSY-2234-1 MBS-2234-1 MBS-2010-1 MBS-2250 MSY-1915 MSY-2210 MSY-2015 Lifecath 2296.XXX CMS-207 premicath Nutrisafe 2 1015.XXX 368.42R 1022.XXX VAMST5.5 VAMST4 VAMST3.5 VAMST6 473460 Vytaline Midlines VYML AMS-7000-1 AMS-7870CP-21 AMS-8354CP-3 375185 AMS-8093CP AMS-8405CP-1 AMS-7066CP-1 AMS-9478CP-1 AMS-8142CP-1 AMS-8115CP-2 AMS-8485CP-1 AMS-9860-1 AMS-7079LF AMS-9956CP-8 AMS-7100CS AMS-9817CP-3 AMS-9943CP AMS-9940CP-1 AMS-9591CS AMS-8498CP AMS-9872CP AMS-8502CP-2 AMS-9913CP-2 AMS-8227CP-3 AMS-8738CP-1 AMS-8464CP-5 AMS-9942CP-3 AMS-8240CP-1 AMS-8952CP AMS-9788CP-3 AMS-7200 AMS-9857-6 AMS-938-4 AMS-8464CP-6 AMS-8346 AMS-9067CP AMS-8149-5 AMS-9055CP AMS-9788CP-2 AMS-9478CP AMS-9275CP-2 AMS-7639CP AMS-9942CP-6 AMS-8405CP-3 AMS-8344 AMS-9788CP-3A AMS-8346-1 AMS-8465CS AMS-7870CP-22 AMS-9129CP AMS-9860-2 375182 375186 375141 AMS-7180-3 AMS-8251CP-1 AMS-8109CP-1 AMS-8219 AMS-8526CP AMS-9944-1 AMS-8122CP-2 AMS-8141CP AMS-8460CP-2 AMS-9513CS-1 AMS-9818CP-3 AMS-8471CP-2 AMS-9857-4 AMS-9279 AMS-8149-4 AMS-8508CP AMS-9811CP-4 AMS-8108CP-3 AMS-9958CP AMS-7341CP AMS-8292CP-3 AMS-9946CP-6 AMS-9941CP-6 AMS-9941CP-5 AMS-9335CP-2 SHS-1910 SHY-2210 SHY-2010 SHS-2010 SHS-2250 SHS-2015 SHS-2210 SHY-2250 BHS-2015 BHY-2010 BHS-2250 BHS-2034 BHS-1910 BHS-2210 BHY-1915 BHS-2010 BHY-2210 BHY-2234 BHY-2034 BHY-1910 BHY-2250 BHY-2015 BHS-2234 SHS-2034-1 SHY-2010-1 SHS-2234-1 SHY-2034-1 SHS-2210-1 SHS-2010-1 SHS-2034 SHY-1915 SHS-2234 SHY-2015 SHY-2034 SHY-2234 SHY-1910 AMS-635CV-1 AMS-635 Nerve Block Kit AMS-300 AMS-100 AMS-200 BN-3002 AMS-400 AMS-656 PPS-2275 PPS-2210 PPS-2075 PPS-2010 AMS-497 AMS-543 AMS-105-1 AMS-555-1 AMS-385 AMS-285 AMS-755-1 AMS-904 CMS-396 AMS-440 SS-112-1 AMS-629-1 AMS-481 SS-395B AMS-120 AMS-483 AMS-240 AMS-401 KS-332-1 AMS-301 AMS-379-1 AMS-609-1 AMS-674-1 SS-481 AMS-395-1 CMS-814-1 AMS-184-1 Boussignac CPAP Device 5562.X13 AMS-8165CP-3 AMS-7480CS-2 AMS-9837CP-7 AMS-8165CP-3A AMS-9837CP-6 AMS-7074CP-2A AMS-9161CP AMS-9161CPA AMS-9837CP-7A AMS-7073CP AMS-9788CP-4 AMS-9147CP AMS-2087CP AMS-2008 AMS-9777CP AMS-9140-2 AMS-7074CP-2 1262.30N Grip-Lok Vytaline PICCs VYPL VYG CMS-8000 bionector POLYSITE IMPLANTABLE INFUSION PORTS AMS-2001 BN-300 AMS-290 BN-150 BN-160 BN-140 AMS-2000 AMS-1200LRM nutriline CLGY-2234 CLGY-2050 CLG-2210 CLGY-1934 CLG-2015 CLGY-2250 CLGY-2010 LifeGuard CLG-1934-1 CLG-2234-1 CLG-2010-1 CLG-2250-1 CLGY-2034-1 CLGY-2010-1 CLGY-2015-1 CLGY-1910 CLG-1910-1 CLG-2210-1 CLGY-2234-1 CLG-2010 CLGY-2034 CLG-2034 CLG-1910 CLGY-2015 CLG-2250 CLGY-2210 CLG-1934 CLG-2234 CLG-2050 AMS-427 SS-426 AMS-428 AMS-426-1 AMS-7086 AMS-7070 AMS-729CP-3 VYAA Vitalmix AMS-BAG Filter and Fluid Connector AMS-539-2 MSPT-010878 AMS-539-3 AMS-8182-1 AMS-537 AMS-9034CS AMS-728CS AMS-865CP AMS-875CS AMS-624TG-6 AMS-712CP-1 AMS-896CP-1 AMS-846CP AMS-813CP AMS-970CP AMS-9501-3 AMS-953CS 375200 AMS-772AT AMS-983CS-2 AMS-712CP AMS-9010CP AMS-921CP 375198 AMS-872CP AMS-987AG-1 AMS-785CP AMS-626TGSLF AMS-804CP AMS-797CS 375201 AMS-759CP-1 AMS-744CP AMS-968CP-1 AMS-957CP AMS-926CPS AMS-623TG-6LF AMS-905CS AMS-793CP-1 AMS-858CP-2 AMS-917CP AMS-823CP AMS-908AT-1 AMS-928CS AMS-834T AMS-769VG-1 375179 AMS-827CP-1 AMS-696 AMS-845CS-1 AMS-804CP-1 AMS-623T-6 AMS-9501-1 AMS-627ATG-5 AMS-912CP-2 AMS-769VG-2 AMS-7517CPA-1 AMS-905CS-1 AMS-872CP-1 AMS-849CP AMS-9983CP-2 AMS-737CP AMS-827CP-2 AMS-859CS-4 AMS-869CP AMS-9049CS AMS-8476 AMS-8481 AMS-850TC V-Cutter Leaderflex VYLF MUCAID WITH SUCTION C AMS-8453-1 AMS-8307-1 AMS-8368 AMS-9979 AMS-582 VYG-423-1 AMS-423-1 KS-122-2 AMS-122-1 AMS-975FO AMS-494 AMS-577-1 AMS-532 SS-933-1 AMS-292-2 KS-975NF-2 AMS-541 AMS-975-1 KS-975-2 AMS-975NF AMS-998-1 AMS-295-1 KS-222-2 AMS-934-1 AMS-451 AMS-565 AMS-490 AMS-570 AMS-492 Bionector Extension Set AMS-900CV AMS-923CP AMS-8070CP VY-MAXPRO AMS-8423CP AMS-9868CP-3 AMS-8180-3CP AMS-9377CP-2A AMS-9983CP-1 AMS-6186CP HCT8874VA-VA AMS-8186CP AMS-8198-1 AMS-9140A AMS-9294CS AMS-9437CP-2 AMS-8508CP-2 AMS-9734 AMS-8010CP-1 AMS-8198CS AMS-8054CP AMS-9021CP-1A AMS-9294 AMS-9018CP AMS-9437CP-2A VYMAXBASIC HCT8198-VA AMS-9983CP-1A AMS-8526CP-2 AMS-9849-1 AMS-9152CP-2 AMS-8034CP AMS-9048CP-1 HCT8874VA-V AMS-9140-1 AMS-9038CS-1A AMS-750 AMS-7192CS-3 AMS-9021CP-1 AMS-9868CP-3A AMS-9214CP-1 AMS-9046CP AMS-7058CP AMS-7063-1 AMS-9140 AMS-7072CS AMS-8199 AMS-7192CS-4 AMS-8345CP-1 AMS-9152CP-1 AMS-8126CP-2A AMS-9192CP AMS-7160CPA AMS-7104CP AMS-8023CP-1A AMS-9540CP AMS-9870CP VY-MAX VSKTLS-PA AMS-8517CP AMS-7170CP AMS-8126CP-2 AMS-8461CS AMS-7192CS-8 AMS-599 AMS-8181CP VSKTLS-VYC AMS-8062CP AMS-9093CP AMS-6180CP AMS-9152CP Vitalmix Bag AMS-483C AMS-884-2T AMS-375 CMS-608 AMS-546-2 AMS-944 AMS-540-1 AMS-485-1 AMS-519-1 AMS-542 BN-762 AMS-803 AMS-467 SS-461 AMS-467C AMS-176 AMS-945 AMS-887-4 SS-885-2 AMS-500NS AMS-500 Premicath CMS-5000 AMS-8133 AMS-8475

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility