Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011287770

FEI Number

3011287770

Entity Name

RODIMEDI & ASSOCIATES INC.

City/State/Country

Alt de San Lorenzo, PR, US

Establishment Address

Carr. 181, 201 Calle Jose de Diego, Plaza Rodimedi, Alt de San Lorenzo, PR 00754, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

RODIMEDI & ASSOCIATES INC. (Owner Number: 10082352)

Owner / Operator Contact Address

CARR. 189 KM. 2.0, URB. INDUSTRIAL CAGUAX, CAGUAS, PR 00726, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K163093

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-07-12
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-07-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-02-24
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2024-04-02
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-07-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-07-12
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-07-12
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2025-03-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-07-15

Official Correspondent

ORLANDO J RODRIGUEZ MEDINA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RODIMEDI & ASSOCIATES 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011287770. Last updated year: 2026. Please use registration number 3011287770 when referencing this establishment in official correspondence.