MicroMax Blender

GUDID 00853061006111

High Flow System

MAXTEC, LLC

Oxygen/air breathing gas mixer, hospital

• Primary Device ID: 00853061006111
• NIH Device Record Key: 3d9ced2a-093e-495c-98a1-631ac9f580c6
• Commercial Distribution Discontinuation: 2019-05-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MicroMax Blender
• Version Model Number: R203P14-006
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853061006111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053232

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: 2
• Public Version Date: 2019-05-07
• Device Publish Date: 2019-01-14

On-Brand Devices [MicroMax Blender]

• 00817770021452: High Flow NIST Armstrong
• 00817770021445: High Flow DISS Armstrong
• 00853061006258: High Flow Diss Spanish Labeled
• 00853061006197: Low Flow DISS Dextro Labeled
• 00853061006173: Low Flow DISS without case
• 00853061006111: High Flow System
• 00853061006104: Low Flow System