Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021607937

FEI Number

3021607937

Entity Name

Ventis Medical Inc

City/State/Country

Princeton, NJ, US

Establishment Address

515 Executive Dr, Princeton, NJ 08540, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Ventis Medical Inc. (Owner Number: 10091988)

Owner / Operator Contact Address

2 Stout Rd, Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240807

PMA Number

N/A

All Registered Proprietary Names

VM-531UEN OXYGEN ENRICHMENT KIT Herovent VM2000 Emergency and Transport Ventilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2026-02-17
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-11-22

Official Correspondent

Karen Laub

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ventis Medical 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
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021607937. Last updated year: 2026. Please use registration number 3021607937 when referencing this establishment in official correspondence.