Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015437221

FEI Number

3015437221

Entity Name

Z-MEDICA, LLC

City/State/Country

North Haven, CT, US

Establishment Address

222 Universal Drive, Distribution Facility Only, North Haven, CT 06473, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Z-MEDICA, LLC (Owner Number: 9048106)

Owner / Operator Contact Address

4 FAIRFIELD BLVD., --, Wallingford, CT 06492, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181641

PMA Number

N/A

All Registered Proprietary Names

QuikClot Control+ QuikClot Combat Gauze, QuikClot EMS, QuikClot Combat Gauze TraumaPad, QuikClot Bleeding Control Dressing QuickClot Control+ Hemostatic Device QuikClot Interventional Phokus Nonwoven Bandage QuikClot Control+ QuikClot Interventional QuikClot Hemostatic Dressings, QuikClot 2x2, QuikClot 4x4, QuikClot TraumaPad, QuikClot Z-Fold, QuikClot Roll QuikClot Radial

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POD	Temporary, Internal Use Hemostatic	General, Plastic Surgery	Class 2	878.4454	2017-07-06
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2007-11-14
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2025-04-14
POD	Temporary, Internal Use Hemostatic	General, Plastic Surgery	Class 2	878.4454	2025-04-14
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2009-05-13
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2014-04-25
POD	Temporary, Internal Use Hemostatic	General, Plastic Surgery	Class 2	878.4454	2023-03-02
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2014-02-18
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2014-02-18
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2020-06-02

Official Correspondent

Divya Raman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Z-MEDICA, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004138549	Z-MEDICA, LLC	Wallingford, CT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08
K040208	Tz Medical, Inc.	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	2004-05-11

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1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US
3011137372	Teleflex Medical LLC	Morrisville, NC, US
1219313	CARWILD CORP.	NEW LONDON, CT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015437221. Last updated year: 2026. Please use registration number 3015437221 when referencing this establishment in official correspondence.