Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009348423

FEI Number

3009348423

Entity Name

DRAEGER, INC.

City/State/Country

Houston, TX, US

Establishment Address

7256 S. Sam Houston W. Parkway, Suite 100, Houston, TX 77085, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Draeger, Inc. (Owner Number: 10052404)

Owner / Operator Contact Address

3135 Quarry Road, Telford, PA 18969, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Draeger Alcotest 5820 Draeger Alcotest 3820 Draeger Alcotest 5000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2016-07-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Draeger, Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009348423. Last updated year: 2026. Please use registration number 3009348423 when referencing this establishment in official correspondence.