Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1530671

FEI Number

3001639729

Entity Name

HEALTH CARE LOGISTICS, INC.

City/State/Country

Urbancrest, OH, US

Establishment Address

3605 URBANCREST INDUSTRIAL DR., Urbancrest, OH 43123, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Health Care Logistics, Inc. (Owner Number: 9032160)

Owner / Operator Contact Address

3605 URBANCREST INDUSTRIAL DR., --, Urbancrest, OH 43123, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterile Permanent Waterproof Utility Markers Medication Organizer Chemotherapy Disposal Slider Bag Chemotherapy Waste Bag Adapter Cap Tapered Bottle Adapter Oral to Oral Connector Biohazard Transport Bags Sterile Female-Female Luer Lock Connectors Enema Kit Low Dose ENFit® Syringe and Cap Kit Pill Cutter/Crusher Quiet Crusher Disposable Full Face Shield Double-Ended Transfer Needle Suregrip Transfer Pins BetterShield Disposable Face Shield Chemo Vent Bouffant Cap IV Lock Box Gardian Syringe Filter Tamper Tuf

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2003-05-20
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2025-05-08
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2025-04-17
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	1998-01-12
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2025-12-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-06-11
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-06-11
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2002-05-13
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2025-04-17
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2019-12-11
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-06-11
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-04-17
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2007-12-19
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2002-05-13
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2026-03-10
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2003-04-29
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	1998-01-12
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2025-06-23
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2024-11-04

Official Correspondent

Tomeka Harris

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Health Care Logistics, Inc.

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
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
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

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 1530671. Last updated year: 2026. Please use registration number 1530671 when referencing this establishment in official correspondence.