Sol-Millennium Medical, Inc.

FDA Device Registration & Listing · Chicago, IL, US · Registration 3014312726

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014312726
FEI Number
3014312726
Entity Name
Sol-Millennium Medical, Inc.
City/State/Country
Chicago, IL, US
Establishment Address
311 S Wacker Drive, Suite 4100, Chicago, IL 60606, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Sol-Millennium (Owner Number: 10035370)
Owner / Operator Contact Address
311 S Wacker Drive, Suite 4100, Chicago, IL 60606, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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 Hypodermic Single Lumen Needle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-05-23
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2017-05-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-05-29
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2024-03-13
QNQ Low Dead Space Piston Syringe General Hospital Class 2 880.5860 2026-06-19
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2026-06-19
FMF Syringe, Piston General Hospital Class 2 880.5860 2026-06-19
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-01-11
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2014-04-06
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2024-01-08
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-05-02
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2025-05-02
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-05-23
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-01-24
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-01-24
QNQ Low Dead Space Piston Syringe General Hospital Class 2 880.5860 2025-03-18
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2020-09-25
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-03-26
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-03-26
MEG Syringe, Antistick General Hospital Class 2 880.5860 2011-12-19
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2011-12-19
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2024-01-08
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2011-12-19
MEG Syringe, Antistick General Hospital Class 2 880.5860 2016-11-30
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-04-29
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-05-16
QUF Hearing Aid, Air-Conduction, Over The Counter Ear, Nose, Throat Class 1 874.3300 2024-01-08
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-05-29
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2019-02-04
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2022-03-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2022-03-25
POR Parenteral Administration Kit General Hospital Class 2 880.5440 2025-11-26
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-12-20
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-02-12
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-01-11
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2013-05-29
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2011-02-24
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2022-09-01
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-09-01
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-01-31
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2022-01-31
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-05-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-05-29
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-05-29
MEG Syringe, Antistick General Hospital Class 2 880.5860 2014-06-16
FMF Syringe, Piston General Hospital Class 2 880.5860 2011-12-19
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-01-04
MDA Elastomer, Silicone, For Scar Management General, Plastic Surgery Class 1 878.4025 2024-04-04
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2025-03-18
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-03-18
MEG Syringe, Antistick General Hospital Class 2 880.5860 2025-03-18
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2024-05-23
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-11-07
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2020-09-25
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-06-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-05-29
MEG Syringe, Antistick General Hospital Class 2 880.5860 2011-12-19
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2024-01-08
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-05-23

Official Correspondent

Edward Roles

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sol-Millennium
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014312726. Last updated year: 2026. Please use registration number 3014312726 when referencing this establishment in official correspondence.
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