FDA.reportPublic FDA data

Emergency Ventilator Complete Package

Primary DI
00850070543033
Brand
Emergency Ventilator Complete Package
Company
Ventis Medical Inc.
Model
VCF-2000
Device description
Complete package containing VM-2XXX Series HeroVent Emergency and Transport ventilator and its accessories.
Published
2025-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
00850070543033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850070543033008500705430338500705430330850070543033

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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
609-373-6229inquiries@ventismed.com

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
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
00850070543002HeroVentVM-20002025-10-17
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
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