Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040389677

FEI Number

3040389677

Entity Name

RRDONNELLEY

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 101, No.,28, Huangshahexi Road, Liaobu Town, Dongguan, Guangdong Province, China, Dongguan Guangdong 523058, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RRDonnelley (Owner Number: 10093913)

Owner / Operator Contact Address

Room 101, No.,28, Huangshahexi Road, Liaobu Town, Dongguan, Guangdong Province, China, Dongguan, CN-GD 523058, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Elvie Pump Elvie Stride Elvie Stride 2 cooling gel nipple pads Elvie Nipple Cushions Willow go

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-12-18
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-12-18
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-12-18
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2025-08-04
PWA	Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	Obstetrics/Gynecology	Class 1	884.5150	2025-12-18
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-08-04

Official Correspondent

Lee Rush

US Agent Details

Lee Rush Email: lee.m.rush@rrd.com Phone: (763) 3182035

Related Public Records

Same Entity

RRDonnelley

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006371704	RR DONNELLEY-SUPPLY CHAIN SOLUTIONS	Plover, WI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040389677. Last updated year: 2026. Please use registration number 3040389677 when referencing this establishment in official correspondence.