Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1423982

FEI Number

3001677091

Entity Name

MEDEFIL, INC.

City/State/Country

GLENDALE HEIGHTS, IL, US

Establishment Address

250 WINDY POINT DR., GLENDALE HEIGHTS, IL 60139, US

Establishment Type(s)

Manufacture Medical Device,Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MEDEFIL, INC. (Owner Number: 9036760)

Owner / Operator Contact Address

250 WINDY POINT DR., --, Glendale Heights, IL 60139, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K020996

PMA Number

N/A

All Registered Proprietary Names

Heparin I. V. Flush Syringe Normal Saline I. V. Flush Syringe Normal Saline I. V. Flush Syringe - Sterile Field Ready Heparin I. V. Flush Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NZW	Heparin, Vascular Access Flush	General Hospital	Class 2	880.5200	2010-10-19
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2006-01-12
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2012-12-13
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2006-01-12

Official Correspondent

PRADEEP AGGARWAL

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDEFIL, INC.

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

View Entity Profile →

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.

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3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3008518459	EXCELSIOR MEDICAL LLC	Freehold, NJ, US
2027791	EXCELSIOR MEDICAL LLC	NEPTUNE, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1423982. Last updated year: 2026. Please use registration number 1423982 when referencing this establishment in official correspondence.