Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003865400

FEI Number

3003865400

Entity Name

Maruho Plastic Solutions

City/State/Country

ERIE, CO, US

Establishment Address

425 BONNELL AVE., ERIE, CO 80516, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Maruho Plastic Solutions (Owner Number: 9045656)

Owner / Operator Contact Address

425 BONNELL AVE., --, Erie, CO 80516, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

StaySafe Clip; StaySafe Handi-Tool; StaySafe Organizer; StaySafe Organizer Holder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2019-06-06

Official Correspondent

Kelsey Fox

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Maruho Plastic Solutions

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
K822361	Travenol Laboratories, S.A.	DIANEAL SOLUTION EXCHANGE DEVICE #5C4193	1982-08-16
K933687	R & D Batteries, Inc.	R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260	1994-02-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2020	Baxter Healthcare Corporation	2	L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

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1225714	Fresenius Medical Care Renal Therapies Group, LLC	Waltham, MA, US
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US
9680579	Sterigenics Radiation Technologies Canada, Inc	PORT COQUITLAM British Columbia, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003865400. Last updated year: 2026. Please use registration number 3003865400 when referencing this establishment in official correspondence.