VORTRAN Airway Pressure Monitor

Basic Information

• Brand Name: VORTRAN Airway Pressure Monitor
• Primary DI: 10637320039006
• Version / Model: APM-3900
• Catalog Number: APM-3900
• 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: 2016-06-14
• Public Version: 4
• Public Version Date: 2019-10-16
• Public Version Status: Update
• Public Device Record Key: dad08cd2-75a2-4e1c-b1d7-04b7d15ecb29

Device Description

The APM (Airway Pressure Monitor) is a battery operated, portable, self-contained device that is connected to the patient via the connection kit to monitor the cycling conditions of resuscitators. It give clinicians patient ventilation parameters (PIP, PEEP, Respiration Rate, I:E ratio) and provides visual alarm display with flashing LED and loud audible alarm. It allows clinicians to have a true value of patient status during ventilation similar to a full-featured ventilator. It is easy to set up and use. Offers different connection kit options.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	868.2600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57831	Airway pressure/oxygen monitor	A mains electricity (AC-powered) device designed to continuously measure and display the breathing circuit pressure and oxygen (O2) concentration levels of respiratory gases delivered to a patient through positive pressure ventilation systems such as continuous positive airway pressure (CPAP) systems or ventilator respiratory circuits. It typically includes pressure and O2 level displays, alarms to signal pressure and O2 levels that exceed specified limits, and has connectors to allow attachment to the respiratory equipment; it is used for neonatal, paediatrics and adults. It may contain one or more rechargeable battery for independent/mobile use or when mains power is not available.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10637320039006	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K103639	000