BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SAFEGUARD US OPERATING, LLC

    Reg #: 3008258694 · FEI: 3008258694 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    44
    Establishment Types
    5
    Classifications
    34

    Registration Details

    Registration Name
    SAFEGUARD US OPERATING, LLC
    Registration Number
    3008258694
    FEI Number
    3008258694
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    13359 Reese Blvd. E
    City
    Huntersville
    State
    NC
    ZIP
    28078
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133528

    Owner / Operator

    Firm Name
    Safeguard US Holdco, Inc.
    Operator Number
    10031323
    Address
    13359 Reese Blvd. E
    City
    Huntersville
    State
    NC
    Postal Code
    28078
    Country
    US
    Correspondent
    Kimberly Reed

    Products

    Device Name Product Code
    Bandage, Elastic FQM
    Intravenous Extension Tubing Set OJA
    Tube Tracheostomy And Tube Cuff JOH
    Stretcher, Hand-Carried FPP
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Dressing, Wound, Occlusive NAD
    Warmer, Blood, Non-Electromagnetic Radiation BSB
    Warmer, Thermal, Infusion Fluid LGZ
    Body Fluid Clean Up Kit OKG
    Catheter Introducer Kit OFC
    Pack, Hot Or Cold, Disposable IMD
    Needle, Catheter GCB
    Bedding, Disposable, Medical KME
    Tourniquet, Nonpneumatic GAX
    Belt, Pelvic, Traction HSQ
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Cricothyrotomy Kit OGP
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Kit, Surgical Instrument, Disposable KDD
    First Aid Kit Without Drug OHO
    Sling, Arm ILI
    Dressing, Compression MHW
    Accessories, Catheter KGZ
    Gauze / Sponge,Nonresorbable For External Use NAB
    Sheet, Burn FPY
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Airway, Nasopharyngeal BTQ
    First Aid Kit With Drug LRR
    I.V. Start Kit LRS
    Blood Transfusion Kit POQ
    Needle, Aspiration And Injection, Disposable GAA
    Clamp, Vascular DXC

    Proprietary Names

    Safeguard GO IO Safeguard - HH Surgical Airway APE SAVe II+ Universal Splint Sentinel Chest Seal Warrior Extreme Individual Personal Protective Equipment Safeguard - chest tube insertion Safeguard - Advanced Hypothermia Mgt HAWK DART Safeguard - emergency blanket HAWK Mgt Set SWAT-T Prometheus Safeguard - chest seals SAVe I conversion kit Safeguard Medical MOJO EMT TMT Holster MARCH Bleeding Control Maritime Safeguard - Public Safety Cravat BDX Battle Bandage Battle Wrap Rolled gauze Gauze TACWrap Pre-Lubricated Nasal Airway Nasal Airway Poolside Saline Lock IV Inclusion Fresh Whole Blood (FWB) Low Titer (LT) Sentinel Chest Trauma Kit Safeguard - Chest decompression set CROC

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)