MAXVENTURI

Basic Information

• Brand Name: MAXVENTURI
• Primary DI: 00817770020486
• Version / Model: R211P03-126
• Company Name: MAXTEC, LLC
• Labeler DUNS: 169911828
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 5
• Public Version Date: 2019-05-07
• Public Version Status: Update
• Public Device Record Key: ae83e8a3-e240-46d2-a4f4-121c8c03d7dd
• Distribution End Date: 2019-05-06

Device Description

MaxVenturi International Dextro Labeled with DISS Fitting

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	868.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46049	Respiratory oxygen monitor, battery-powered	A battery-powered instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting (e.g., O2 in an anaesthesia or ventilator breathing circuit, oxygen tent, oxygen therapy device/system tubing). It typically consists of an electronic unit with a display to show actual values of percentage of O2 concentration, a sensor to detect the O2 values, control knobs or buttons, and an alarm to alert when O2 values are beyond a predetermined range.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817770020486	GS1

Premarket Submissions

Submission Number	Supplement Number
K063488	000