Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005060859

FEI Number

3005060859

Entity Name

MARIAN MEDICAL, INC.

City/State/Country

Barbourmeade, KY, US

Establishment Address

3600 Chamberlain Ln Ste 106, Barbourmeade, KY 40241, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MARIAN MEDICAL, INC. (Owner Number: 9070940)

Owner / Operator Contact Address

3600 Chamberlain Lane, #106, Louisville, KY 40241, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042112

PMA Number

N/A

All Registered Proprietary Names

ACE Stopper /Stoma Plug Medicina Feeding Tubes with ENFit Connectors

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2012-07-20
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2007-02-05

Official Correspondent

SANDRA WINKLER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MARIAN MEDICAL, 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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Similar Registrations

Registration Number	Establishment Name	Location
3032900656	CAREWELL FAMILY, INC	Coral Gables, FL, US
3011446173	FISCHER MANUFACTURING LLC	Fairfield, OH, US
3010048541	ABENA NORTH AMERICA, INC.	Oceanside, CA, US
3016452317	GUANGDONG CHUANTIAN SANITARY PRODUCTS CO.,LTD	Zhongshan Guangdong, CN
3012162353	INTELLIGENT FABRIC TECHNOLOGIES (NORTH AMERICA) INC.	Markham Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005060859. Last updated year: 2026. Please use registration number 3005060859 when referencing this establishment in official correspondence.