MaxBlend2

Basic Information

• Brand Name: MaxBlend2
• Primary DI: 00853061006333
• Version / Model: R229P02-004
• Company Name: MAXTEC, LLC
• Labeler DUNS: 169911828
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-27
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: c4923694-217d-4de4-8ab4-b7518361657f

Device Description

MaxBlend2, High Flow, Bird with NIST

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: 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
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	00853061006333	GS1

Premarket Submissions

Submission Number	Supplement Number
K161718	000