MAXFLO2

GUDID 00817770020783

Low Flow System

MAXTEC, LLC

Oxygen/air breathing gas mixer, hospital

• Primary Device ID: 00817770020783
• NIH Device Record Key: 2d140e71-d43c-4c29-aa9e-1d967e5108c8
• Commercial Distribution Discontinuation: 2019-05-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MAXFLO2
• Version Model Number: R223P01-006
• Company DUNS: 169911828
• Company Name: MAXTEC, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817770020783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113232

FDA Product Code

• BZR: Mixer, Breathing Gases, Anesthesia Inhalation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-27

On-Brand Devices [MAXFLO2]

• 00817770020806: MaxFlo2 Mini 0-70 LPM
• 00817770020790: High Flow System
• 00817770020783: Low Flow System
• 00853061006159: High Flow Spanish Labeled
• 00853061006142: High Flow with MaxO2+ Nist Fitting Kit
• 00853061006135: Low Flow with MaxO2+ DISS Fitting Kit
• 00853061006067: High Flow with MaxO2+, DISS Fitting Kit
• 00853061006050: Low low with MaxO2+A, DISS Fitting Kit
• 00853061006036: High Flow with NIST Fitting
• 00853061006029: MaxFlo2 High Flow with DISS Fitting
• 00853061006005: MaxFlo2 Low Flow DISS Fitting