Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1420054

FEI Number

1420054

Entity Name

LSL HEALTHCARE

City/State/Country

Niles, IL, US

Establishment Address

6200 W Howard St, Niles, IL 60714, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

LSL Healthcare (Owner Number: 1420054)

Owner / Operator Contact Address

6200 W. Howard St, --, Niles, IL 60714, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101387

PMA Number

N/A

All Registered Proprietary Names

LSL Tracheal Tube BEDPAN LSL Peritoneal Catheter LSL Biopsy Tray LSL Iodine LSL Blood and Urine Collection Kit LSL SCISSORS LSL Urine Collection Cup SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE CONTAINER, SPECIMEN, STERILE Bed Patient Monitor TRAY, SURGICAL, INSTRUMENT Suture Removal Kit LSL Ureteral Catheter SCISSORS, MEDICAL, DISPOSABLE RONGEUR, NASAL URINAL BOUGIE, UROLOGICAL TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS LSL Blood Collection SYRINGE, IRRIGATING (NON DENTAL) LSL Medical Fiber LSL Surgical Tray Tracheostomy Tray LSL Thermometer Kit, Surgical Instrument, Disposable TOURNIQUET, NONPNEUMATIC LSL Conduction Needle LSL Body Fluids Barrier Kit BRUSH, SCRUB, OPERATING-ROOM LSL Surgical Razor LSL Blade LSL Hypodermic Needle CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY Circumcision Tray LSL Arthogram Tray Bath, Sitz, Nonpowered LSL Polymer Patient Examination Glove SYRINGE, ENT DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE LSL Electronic Thermometer LSL Urinary Drainage Collection Kit Catheterization Kit COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER BASIN, EMESIS Catheter Care Tray LSL Surgical Mask CATHETERS, SUCTION, TRACHEOBRONCHIAL LSL Medical Stocking Suture Kit LSL Needle Catheter Urine hCG Pregnancy Combo Cassette RETRACTOR LSL Eye Shield Patient Personal Hygiene Kit LSL Dressing Change Tray LSL Surgical Drape LSL Surgical Mask LSL Body Fluid Clean Up Kit Removable Stapler LSL Liquid Medication Dispenser LSL Bandage FORCEPS, GENERAL & PLASTIC SURGERY ACCESSORY, SURGICAL APPAREL LSL STETHOSCOPE, MANUAL RETRACTOR, ALL TYPES FORCEPS, BIOPSY, GYNECOLOGICAL LSL Bandage LSL Examination Glove LSL Skin Marker LSL General Surgical Tray LSL Electronic Thermometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2020-04-25
FOB	Bedpan	General Hospital	Class 1	880.6730	1987-04-01
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2018-12-17
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	2013-02-02
IAL	Iodine (Tincture)	Pathology	Class 1	864.4010	2013-02-02
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2012-12-20
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-02-04
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2025-05-21
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	1987-04-01
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	1987-04-01
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2012-09-15
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-09-09
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2011-12-17
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2013-02-11
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1985-06-12
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	1985-06-12
FNP	Urinal	General Hospital	Class 1	880.6730	2011-12-12
FAX	Bougie, Urological	Gastroenterology, Urology	Class 1	876.5520	1987-04-01
FKG	Tray, Start/Stop (Including Contents), Dialysis	Gastroenterology, Urology	Class 1	876.5820	2011-12-12
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2022-04-21
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2011-08-29
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2013-02-05
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-10-05
OGW	Tracheostomy Kit	Anesthesiology	Class 2	868.5800	2012-09-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-06-15
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	1987-04-01
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2011-12-09
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2019-08-23
OKH	Body Fluids Barrier Kit	General, Plastic Surgery	Class 2	878.4040	2013-02-02
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2011-12-12
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-09-11
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2020-07-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-08-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-08-23
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1985-06-12
OHG	Circumcision Tray	Obstetrics/Gynecology	Class 2	884.4530	2012-09-15
OII	Arthrogram Tray	Radiology	Class 2	892.1650	2017-10-04
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	1983-03-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-08-19
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	1987-04-01
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2004-08-20
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-25
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2004-08-20
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2012-09-15
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2012-09-08
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	1987-04-01
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2012-09-11
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-17
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2011-12-12
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2014-04-23
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2012-09-11
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2018-12-17
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2025-05-21
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1984-02-07
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-31
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2012-09-10
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2012-09-10
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2020-04-11
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-25
OKG	Body Fluid Clean Up Kit	General, Plastic Surgery	Class 2	878.4040	2013-07-10
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2012-09-15
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2013-02-04
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2005-09-19
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1985-06-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2011-12-12
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2021-02-09
EIG	Retractor, All Types	Dental	Class 1	872.4565	1985-06-12
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	1985-06-12
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2020-07-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-04-25
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2013-02-02
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2012-09-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-25

Official Correspondent

Demetrius Bridges

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LSL Healthcare

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
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1420054. Last updated year: 2026. Please use registration number 1420054 when referencing this establishment in official correspondence.