Ventrain

Basic Information

• Brand Name: Ventrain
• Primary DI: 08718969590044
• Version / Model: 2618700
• Catalog Number: 2618700
• Company Name: Ventinova Medical B.V.
• Labeler DUNS: 491071834
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-09
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 2a8b6005-5fcc-4395-8254-f2392f240fdb

Device Description

Ventrain® is the only ventilation device that provides full ventilation in "Cannot Intubate, Cannot Ventilate" situations. Ventrain® not only supplies oxygen during the inspiration phase, but also uses suction to actively remove gas from the lungs during the expiration phase. This active expiration has been named Expiratory Ventilation Assistance (EVA®). Ventrain® is a single-use ventilation device specifically designed for difficult or obstructed airway situations. Based on EVA® it offers 1) effective, full ventilation of a patient with an obstructed upper airway, and 2) more therapeutic options in cases involving difficult airways. See further www.ventinova.nl/products/ventrain.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	868.5925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61724	Manual jet ventilation device	A portable, manually-operated, noninvasive device intended to be used in conjunction with a separate compressed oxygen (O2) source and airway access device (e.g., cricothyrotomy kit) for transtracheal ventilation of a patient in an emergency situation where there is complete or partial obstruction of the airways. It includes a small unit with an on/off button, which a healthcare professional is intended to manually turn on to release O2 for patient inspiration and turn off to allow expiration; it may also include medical grade tubing and a medical gas regulator for connection to higher pressure (e.g., >50psi) O2 sources; it is not intended to provide automated ventilation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08718969590044	GS1
Package	08718969590051	GS1	Cardbox	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K132759	000