ventismed.comVM-2000
Ventis Medical, Inc.
Ventis Medical Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3021607937 | 3021607937 | Ventis Medical Inc | 1 | N | 2026-01-01 | 515 Executive Dr Princeton NJ US 08540 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850070543033 | Emergency Ventilator Complete Package - Complete package containing VM-2XXX Series HeroVent Emergency and Transport ventilator and its accessories. | 609-373-6229 | inquiries@ventismed.com |
| 00850070543057 | Flow Sensor Cable - Flow Sensor Cable for VM-2XXX Series HeroVent Emergency and Transport ventilators. | 609-373-6229 | inquiries@ventismed.com |
| 00850070543064 | Flow Sensor - Flow Sensor for VM-2XXX Series HeroVent Emergency and Transport ventilators. | 609-373-6229 | inquiries@ventismed.com |
| 00850070543071 | ETCO2 Sensor - ETCO2 sensor for VM-2XXX Series HeroVent Emergency and Transport ventilators. | 609-373-6229 | inquiries@ventismed.com |
| 00850070543088 | Inlet Filter for VM-2000 - Inlet Filter for VM-2XXX Series HeroVent Emergency and Transport ventilators. | 609-373-6229 | inquiries@ventismed.com |
| 00850070543095 | Flow Sensor Reusable - Flow Sensor Reusable for VM-2XXX Series HeroVent Emergency and Transport ventilators. | 609-373-6229 | inquiries@ventismed.com |
| 00850070543101 | Carry Case - Carry Case for VM-2XXX Series HeroVent Emergency and Transport ventilators. | 609-373-6229 | inquiries@ventismed.com |
| 00850070543118 | Oxygen Enrichment Kit - Oxygen Enrichment Kit for VM-2XXX Series HeroVent Emergency and Transport ventilators | 609-373-6229 | inquiries@ventismed.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 333949 | 2063419282 | K240807 | VM-2000 | CBK | 2024-08-13 |
| 333949 | 1397603260 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| CBK | 1 | 2024-08-13 |
PMN#
GUDID#
Emergency Ventilator Complete Package - Complete package containing VM-2XXX Series HeroVent Emergency and Transport ventilator and its accessories.
2025-12-31
Oxygen Enrichment Kit - Oxygen Enrichment Kit for VM-2XXX Series HeroVent Emergency and Transport ventilators
2025-10-21
Carry Case - Carry Case for VM-2XXX Series HeroVent Emergency and Transport ventilators.
2025-10-21
Flow Sensor Reusable - Flow Sensor Reusable for VM-2XXX Series HeroVent Emergency and Transport ventilators.
2025-10-21
Inlet Filter for VM-2000 - Inlet Filter for VM-2XXX Series HeroVent Emergency and Transport ventilators.
2025-10-21
ETCO2 Sensor - ETCO2 sensor for VM-2XXX Series HeroVent Emergency and Transport ventilators.
2025-10-21
Flow Sensor - Flow Sensor for VM-2XXX Series HeroVent Emergency and Transport ventilators.
2025-10-21
Flow Sensor Cable - Flow Sensor Cable for VM-2XXX Series HeroVent Emergency and Transport ventilators.
2025-10-21
A.C Power Supply - A.C Power Supply for VM-2XXX Series HeroVent Emergency and Transport ventilators.
2025-10-21
Rechargeable Battery for VM-2000 - Battery pack for VM-2XXX Series HeroVent Emergency and Transport ventilators.
2025-10-17
Primary Battery for VM-2000 - Battery pack for VM-2XXX Series HeroVent Emergency and Transport ventilators.
2025-10-17
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.
2025-10-17