FDA.reportPublic FDA data

HeroVent

Primary DI
00850070543002
Brand
HeroVent
Company
Ventis Medical Inc.
Model
VM-2000
Device description
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.
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240807000VM-2000Ventis Medical, Inc.2024-08-13CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850070543002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850070543002008500705430028500705430020850070543002

GMDN Terms#

Term, Definition table
TermDefinition
Portable electric ventilatorA portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).

Regulatory Flags#

DUNS number
117882866
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850070543033Emergency Ventilator Complete PackageVCF-20002025-12-31
00850070543040A.C Power SupplyVM-4202025-10-21
00850070543057Flow Sensor CableVM-5212025-10-21
00850070543064Flow SensorVM-5222025-10-21
00850070543071ETCO2 SensorVM-7012025-10-21
00850070543088Inlet Filter for VM-2000VM-5112025-10-21
00850070543095Flow Sensor ReusableVM-5302025-10-21
00850070543101Carry CaseVM-6102025-10-21
00850070543118Oxygen Enrichment KitVM-5312025-10-21
00850070543019Primary Battery for VM-2000VM-4012025-10-17
00850070543026Rechargeable Battery for VM-2000VM-4022025-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
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08056814676407DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676360DIMARHMC PREMEDICAL SPACBK2025-03-20
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