POM EZ-Lite MF

Basic Information

• Brand Name: POM EZ-Lite MF
• Primary DI: 10851438008116
• Version / Model: 1003-MF
• Company Name: POM MEDICAL, LLC
• Labeler DUNS: 078731530
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-11
• Public Version: 1
• Public Version Date: 2018-08-13
• Public Version Status: New
• Public Device Record Key: 61eb5097-861d-44d5-ac52-42ae287aa1d5

Device Description

Adult Procedural Oxygen Mask - Medium Concentration & CO2 Monitoring (Male to Female)

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	868.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62179	Capnography oxygen mask	A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver oxygen (O2) to a patient's airway, and to sample exhaled respiratory gases for monitoring the patient’s ventilatory status. It includes exhaled air sampling tubing for connection to a carbon dioxide monitor (capnograph), or physiology-monitoring sedation/anaesthesia system, for the measurement of end-tidal carbon dioxide (EtCO2) in expiratory gases; it is typically used during anaesthesia/sedation or bedside monitoring. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20851438008113	GS1		30	In Commercial Distribution
Primary	10851438008116	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172365	000