Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002956991

FEI Number

3002956991

Entity Name

PAS SYSTEMS INTERNATIONAL INC

City/State/Country

Durham, NC, US

Establishment Address

4920 S. Alston Ave., Durham, NC 27713, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

PAS Systems International Inc (Owner Number: 10040583)

Owner / Operator Contact Address

3630 Park 42 Drive, Suite 140C, Cincinnati, OH 45241, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PAS Alcovisor Mercury Breath Alcohol Analyzer Alcovisor Titan Alcovisor Beta Alcovisor Alpha Alcotorch V10 Alcovisor Mars BT Breath Alcohol Analyzer Alcovisor Mark X Alcotorch V9 Alcovisor Saturn PAS Alcovisor Jupiter Breath Alcohol Analyzer Alcovisor Click Breath Alcohol Analyzer Alcovisor Pluto Breath Alcohol Analyzer Alcovisor Deimos PAS Alcovisor Mark V Breath Alcohol Analyzer PAS Alcovisor Jupiter X Breath Alcohol Analyzer PAS Alcovisor Mars Breath Alcohol Analyzer PAS Alcovisor Satellite Breath Alcohol Analyzer Alcotorch V6 Alcovisor Phoebus

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	2012-04-26

Official Correspondent

Siobhan Sheeran

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PAS Systems International 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 3002956991. Last updated year: 2026. Please use registration number 3002956991 when referencing this establishment in official correspondence.