BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sol-Millennium Medical, Inc.

    Reg #: 3014312726 · FEI: 3014312726 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    83
    Establishment Types
    2
    Classifications
    32

    Registration Details

    Registration Name
    Sol-Millennium Medical, Inc.
    Registration Number
    3014312726
    FEI Number
    3014312726
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    311 S Wacker Drive, Suite 4100
    City
    Chicago
    State
    IL
    ZIP
    60606
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163073

    Owner / Operator

    Firm Name
    Sol-Millennium
    Operator Number
    10035370
    Address
    311 S Wacker Drive, Suite 4100
    City
    Chicago
    State
    IL
    Postal Code
    60606
    Country
    US
    Correspondent
    Edward C Roles

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Polymer Patient Examination Glove LZA
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Low Dead Space Piston Syringe QNQ
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Piston FMF
    Dressing, Wound, Drug FRO
    Needle, Aspiration And Injection, Disposable GAA
    Tape And Bandage, Adhesive KGX
    Cap, Surgical FYF
    Syringe, Antistick MEG
    Set, I.V. Fluid Transfer LHI
    Dressing, Wound, Hydrophilic NAC
    Non-Surgical Gown OEA
    Hearing Aid, Air-Conduction, Over The Counter QUF
    Tubing, Noninvasive GAZ
    Mask, Surgical FXX
    Parenteral Administration Kit POR
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Medical Glove, Specialty LZC
    Fentanyl And Other Opioid Protection Glove QDO
    Elastomer, Silicone, For Scar Management MDA
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Cover, Shoe, Operating-Room FXP
    Dressing, Wound, Occlusive NAD
    Syringe, Irrigating (Non Dental) KYZ
    Accessory, Surgical Apparel LYU
    Gauze / Sponge,Nonresorbable For External Use NAB
    Respirator, Surgical MSH
    Bedding, Disposable, Medical KME
    Dispenser, Liquid Medication KYX

    Proprietary Names

    Sol-Care Safety Blood Collection Needle Sol-Care Safety Blood Collection Needle with Pre-attached Holder Sol-M Blood Collection Tube Holder Sol-M Holder with Male Luer Lock Adapter Sol-Care Safety Winged Infusion Set Sol-M Multi Sample Needle Sol-M Blood Culture Holder Sol-Glide Safety Needle Sol-Glide Safety Needle with Syringe Sol-M Blunt Fill Needle Sol-M Blunt Fill Needle with 5 micron filter Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set Hypodermic Single Lumen Needle SOL-M Pen Needle Sol-Guard Solo 0.5 ml Safety Insulin syringe w/Fixed Needle 31G x 8mm SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle SOL-M Slip Tip Syringe (Low Dead Space) w/o needle SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle Sol-M Disposable Bouffant Caps Sol-Care 1, 3, 5, 10 and 20 ml Retractable Safety Syringes Set, i.V. Fluid transfer. Dressing, wound, hydrophilic. EZ Wing Plastic Cannula Sol-Care 0.5ml Retractable Safety Syringes with Fixed Needle Sol-M Isolation Gown SOL-GUARD™ Auto-Disable Syringe Tubes, vials, systems, serum separators, blood collection. Sol-M Non-Conductive Suction Tubing with Scalloped Connectors Sol-M Medical Surgical Mask Insulin Kits Sol-M Eccentric Tip Syringe without Needle Sol-M Slip Tip Syringe without Needle Sol-M Pen Needle Sol-Care Safety Needle SOL-GUARD Safety Needle Dropsafe Safety Needle SolM Lancet SOL-GUARD™ Safety Pull-Button Blood Collection Set SOL-CARE IV Bag Safety Connector Sol-Guard TB Safety Syringe Sol-Guard Insulin Safety Syringe SOL-CARE Luer Lock Syringe w/ Safety Needle Sol-M Luer Lock Hypodermic Syringes Sol-M Luer Lock Syringe Dropsafe Luer Lock Syringe with Safety Needle WINNER Face Mask SILICONE SCAR GEL ULTRA Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Nee Blood Lancets SOL-M Blood Lancets (21G, 26G,28G,30G,32G, 33G) Skin and Wound Cleanser Sol-M Shoe Covers Sol-M Insulin Syringe Sol-M 1.5ml Hypodermic Syringe with fixed needle (Low Dead Space) Sol-M TB Syringe droplet® insulin syringes Droplet Insulin Syringe Sol-Care 0.5 and 1 ml Insulin Retractable Safety Syringes Sol-M Sacrum Silicon Foam dressing with Boarder SOL-CARE Safety Pen Needle Sol-M 60ml Piston Irrigation Syringe Sol-M 100ml Piston Irrigation Syringe Sol-M Ag Silver Calcium Alginate Wound Dressing SOL-M Disposable Surgical Mask SOL-M Medical Surgical Mask SOL-M Medical Procedure Mask Sol-M Luer Lock Syringe without Needle Sol-M Exchangeable Needle SOL-M™ Oral Dispensing Syringe Sol-M Blue Tip Cap Sol-M Red Tip Cap Sol-M Black Tip Cap Tray SOL-M Bottle Adapter SOL-M Blood Transfer Sol-M Luer Adapter Sol-M Blood Collection Needles Sol-Care Safety Blood Collection Needle with holder SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder Sol-M Blood Collection Set SOL-M Blood Collection Tube Holder SOL-CARE Safety Multi-Sample Needle

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility