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Ventis Medical Inc

Matched from indexed company URL: Ventis Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30216079373021607937Ventis Medical Inc1N2026-01-01515 Executive Dr Princeton NJ US 08540

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850070543033Emergency Ventilator Complete Package - Complete package containing VM-2XXX Series HeroVent Emergency and Transport ventilator and its accessories.609-373-6229inquiries@ventismed.com
00850070543040A.C Power Supply - A.C Power Supply for VM-2XXX Series HeroVent Emergency and Transport ventilators.609-373-6229inquiries@ventismed.com
00850070543057Flow Sensor Cable - Flow Sensor Cable for VM-2XXX Series HeroVent Emergency and Transport ventilators.609-373-6229inquiries@ventismed.com
00850070543064Flow Sensor - Flow Sensor for VM-2XXX Series HeroVent Emergency and Transport ventilators.609-373-6229inquiries@ventismed.com
00850070543071ETCO2 Sensor - ETCO2 sensor for VM-2XXX Series HeroVent Emergency and Transport ventilators.609-373-6229inquiries@ventismed.com
00850070543088Inlet Filter for VM-2000 - Inlet Filter for VM-2XXX Series HeroVent Emergency and Transport ventilators.609-373-6229inquiries@ventismed.com
00850070543095Flow Sensor Reusable - Flow Sensor Reusable for VM-2XXX Series HeroVent Emergency and Transport ventilators.609-373-6229inquiries@ventismed.com
00850070543101Carry Case - Carry Case for VM-2XXX Series HeroVent Emergency and Transport ventilators.609-373-6229inquiries@ventismed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3339492063419282K240807VM-2000CBK2024-08-13
3339491397603260

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CBK12024-08-13

PMN#

VM-2000

2024-08-13

Ventis Medical, Inc.

GUDID#

HeroVent - The VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support:- Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask).- Assist/Control (AC), SIMV, CPAP and NPPV modes of ventilation.The ventilator is suitable for use in institutional or transport settings.

Ventis Medical Inc.

2025-10-17