Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001304488

FEI Number

3001304488

Entity Name

PRODUCTOS MEXICANOS DE RESINAS SA DE CV

City/State/Country

ESCOBEDO Nuevo Leon, MX

Establishment Address

AVE DE LAS INDUSTRIAS #313, PARQUE INDUSTRIAL ESCOBEDO, ESCOBEDO Nuevo Leon 66050, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Primeline Industries (Owner Number: 10037228)

Owner / Operator Contact Address

4083 Embassy Parkway, Akron, OH 44333, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Natural Rubber Latex Tubing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2011-06-27

Official Correspondent

Donald Zarle

US Agent Details

Donald Zarle Business: PRIMELINE INDUSTRIES Email: donz@primelineindustries.com Phone: (330) 6686555

Related Public Records

Same Entity

Primeline Industries

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-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3007477849	PATIENT SHIELD CONCEPTS LLC	Denver, CO, US
3019385708	OBP SURGICAL CORPORATION	Lawrence, MA, US
3025831202	TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.	Dongguan City Guangdong, CN
3027150141	SWIFTSURE INNOVATIONS INC.	Pasadena Newfoundland and Labrador, CA
3015337348	Primecare Medical (Suzhou) Co.,Ltd.	Changshu Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001304488. Last updated year: 2026. Please use registration number 3001304488 when referencing this establishment in official correspondence.