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

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
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00814747025253Novaplus Full Face AAV Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025260Novaplus Full Face AAV Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
00814747025277Novaplus Full Face Non Vented Mask, Extra LargeSLEEPNET, CORP.CBK2026-10-23
00814747025284Novaplus Full Face Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025291Novaplus Full Face Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025307Novaplus Full Face Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
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