EXPRESS MANUFACTURING, INC

FDA Device Registration & Listing · Santa Ana, CA, US · Registration 2087572

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2087572
FEI Number
3000140642
Entity Name
EXPRESS MANUFACTURING, INC
City/State/Country
Santa Ana, CA, US
Establishment Address
3519 West Warner Avenue, Santa Ana, CA 92704, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Express Manufacturing, Inc (Owner Number: 10029967)
Owner / Operator Contact Address
3519 West Warner Avenue, Santa Ana, CA 92704, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MIRARI® Cold Plasma System ( GV-M2-01) breathalyzer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-02-03
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2026-02-03
DJZ Devices, Breath Trapping, Alcohol Clinical Toxicology Class 1 862.3050 2021-03-10

Official Correspondent

Margo Connell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Express Manufacturing, 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
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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3012940012 Sutter Medical Technologies USA Inc. Alpharetta, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2087572. Last updated year: 2026. Please use registration number 2087572 when referencing this establishment in official correspondence.
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