Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008518459

FEI Number

3008518459

Entity Name

EXCELSIOR MEDICAL LLC

City/State/Country

Freehold, NJ, US

Establishment Address

317 Fairfield Road, Freehold, NJ 07728, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Medline Industries, LP (Owner Number: 9000300)

Owner / Operator Contact Address

Three Lakes Drive, --, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173348

PMA Number

N/A

All Registered Proprietary Names

0.9% Sodium Chloride Injection, USP, Pre-Filled COP Syringe Heparin Lock Flush, USP SwabFlush® 0.9% Sodium Chloride Injection, USP Saline Flush Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2019-10-10
NZW	Heparin, Vascular Access Flush	General Hospital	Class 2	880.5200	2015-12-21
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2014-06-16
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2018-07-09

Official Correspondent

Stephanie Augsburg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medline Industries, LP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.

Similar Registrations

Registration Number	Establishment Name	Location
3043709866	HANTECH (NINGBO) MEDICAL TECHNOLOGY CO., LTD.	Ningbo Zhejiang, CN
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3014421917	O&M Halyard, Inc.	Alpharetta, GA, US
3016413378	JIAXING TIANHE PHARMACEUTICAL CO., LTD.	Jiaxing Zhejiang, CN
3005934752	MEDXL INC	Pointe-Claire Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008518459. Last updated year: 2026. Please use registration number 3008518459 when referencing this establishment in official correspondence.