MaxFlo2

Basic Information

• Brand Name: MaxFlo2
• Primary DI: 00853061006029
• Version / Model: High Flow DISS
• Catalog Number: R223P02
• Company Name: MAXTEC, LLC
• Labeler DUNS: 169911828
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-01
• Public Version: 3
• Public Version Date: 2019-05-07
• Public Version Status: Update
• Public Device Record Key: adb62919-0230-4aa1-8b9e-249c9371c63b
• Distribution End Date: 2019-05-06

Device Description

MaxFlo2 High Flow with DISS Fitting

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: Yes
• 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
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	868.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44225	Oxygen/air breathing gas mixer, hospital	An independent mechanical device designed for accurate mixing of air and oxygen (O2) with O2 concentrations ranging from 21% to 100% (oxygen/air proportioner) that are appropriated for breathing in patients who need a concentration of O2 above the normal concentration in air. The mixer receives air and oxygen from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. The mixer may deliver the gas to the patient through devices such as ventilators, tracheostomy tubes, endotracheal (ET) tubes, oxygen tents, and/or masks.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853061006029	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	2.4	Pound
Depth	4.7	Inch
Width	3.9	Inch
Height	8.2	Inch

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity