BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HAEMONETICS CORPORATION

    Reg #: 1219343 · FEI: 1219343 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    42
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    HAEMONETICS CORPORATION
    Registration Number
    1219343
    FEI Number
    1219343
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    125 Summer Street
    City
    Boston
    State
    MA
    ZIP
    02110
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK060033

    Owner / Operator

    Firm Name
    Haemonetics Corporation
    Operator Number
    1219343
    Address
    125 Summer St
    City
    Boston
    State
    MA
    Postal Code
    02110
    Country
    US
    Correspondent
    Julie A Ryan

    Products

    Device Name Product Code
    Separator, Automated, Blood Cell, Diagnostic GKT
    Plasma, Coagulation Control GGN
    System, Multipurpose For In Vitro Coagulation Studies JPA
    System, Processing For Frozen Blood KSW
    Pump, Infusion FRN
    Apparatus, Autotransfusion CAC
    Blood Establishment Computer Software And Accessories MMH
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
    System, Automated Platelet Aggregation JOZ
    System, Blood Collection, Vacuum-Assisted, Manual KST
    General Purpose Reagent PPM
    Medical Device Data System OUG
    Separator, Automated, Blood Cell And Plasma, Therapeutic LKN
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Activated Whole Blood Clotting Time JBP

    Proprietary Names

    PCS 2 Plasma Collection System, Wireless (W) Capable Modification TEG 6s Haemonetics Model 215 Automated Glycerolization/Deglycerolization and Cell Washing System ACP215 TEG 5000 R.I.S. Cell Saver Elite PCS2 Plasma Collection System MCS+ 9000 System SafeTrace Tx PCS2, PCS 300, NexSys PCS Cell Saver 5 PlateletMapping MCS+LN8150 Leukotrap Cell Saver 5, Cell Saver 5+ NextGen 3 NexLynk DMS Cell Saver Elite+ TEG 5000 Analyzer PCS2 TEG 6s QC Antiplatelet Reagent TEG Manager InstaMatch 1 MCS+8150 Apheresis System SafeTrace Tx 3.12 Cymbal NexSys PCS NexSys PCS, Persona THERAPEUTIC PLASMA EXCHANGE SET MCS+ TEG 6s Global Hemostasis - HN Cartridge PCS 300, NexSys PCS PCS2 Plasma Collection System with AC Short Prime SmartSuction Harmony PCS 300; NexSys PCS RapidTeg TEG-ACT Test MCS+9000, SDP revision E software, 994CF-CPP series disposable sets BloodTrack NexSys PCS, Express Plus BloodTrack 4.7

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device