VAR (VORTRAN Automatic Resuscitator) with Extension

Basic Information

• Brand Name: VAR (VORTRAN Automatic Resuscitator) with Extension
• Primary DI: 10637320050124
• Version / Model: PCE-5012
• Catalog Number: PCE-5012
• Company Name: VORTRAN MEDICAL TECHNOLOGY 1, INC
• Labeler DUNS: 090508636
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-04
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9b713cf5-a247-4479-8f87-b5962277bd47

Device Description

The VAR® device is a unique single-patient-use, disposable resuscitator. It provides hands-free ventilator support via a mask or endotracheal tube using a continuous gas flow source. The VAR® device can be operated on a compressor, oxygen or compressed air. Since it does not require the use of electricity or batteries, it is an ideal backup ventilator for the management of mass casualty incidents, natural disasters, disease outbreaks, major power outages and other extraordinary emergencies. An additional advantage of the VAR® device is that it does not interfere with MRI and CT scans.

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: No
• 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
57981	Pulmonary resuscitator, pneumatic, single-use	A non-sterile device designed to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through automatic pneumatic-driven pressure cycle functions. It is connected to a source of compressed oxygen (O2) and, if not entrained, medical air via oxygen/air terminal units or gas cylinder(s). It typically includes gas supply tubing, a gas control modulator, gas connector(s), safety valves, and a flex connector to connect to a face mask or endotracheal (ET) tube. It is used in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20637320050121	GS1		10	In Commercial Distribution
Primary	10637320050124	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041473	000