MaxBlend2 R229P02-010

GUDID 00817770025856

MaxBlend2, High Flow 0-15 LPM DISS 50 PSI

MAXTEC, LLC

Oxygen/air breathing gas mixer, hospital

• Primary Device ID: 00817770025856
• NIH Device Record Key: baf3867a-a712-46c9-9f49-924934410127
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxBlend2
• Version Model Number: High Flow
• Catalog Number: R229P02-010
• Company DUNS: 169911828
• Company Name: MAXTEC, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00817770025856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161718

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-22
• Device Publish Date: 2024-08-14

On-Brand Devices [MaxBlend2]

• 00817770021520: MaxBlend2 0-30 LPM AFNOR 50 PSI
• 00817770021513: MaxBlend2 0-3 LPM NIST 50 PSI
• 00817770021506: MaxBlend2 0-15 LPM AFNOR 50 PSI
• 00817770021490: MaxBlend2 0-15 LPM NIST 50 PSI
• 00817770021483: MaxBlend2 0-30 LPM AFNOR 50 PSI
• 00817770021391: AIR/OXYGEN BLENDER,0-15 lpm, NIST, 60 psi
• 00817770021384: AIR OXYGEN BLENDER, 0-30 lpm, NIST, 50 psi
• 00817770021261: Maxblend2 0-15 LPM Bird with DISS and 60 psi
• 00853061006388: MaxBlend2, Low Flow, Bird w/AFNOR
• 00853061006371: MaxBlend2, High Flow, Bird w/AFNOR
• 00853061006333: MaxBlend2, High Flow, Bird with NIST
• 00853061006326: Low Flow with Diss Fitting (BioMed)
• 00853061006319: High Flow with DISS Fitting (BioMed)
• 00853061006265: MaxBlend2 High Flow Bird Blender DISS
• 00853061006043: MaxBlend2 Low Flow Bird Blender DISS Fitting
• 00817770025672: MaxBlend2 High Flow 0-70 LPM Flowmeter DISS Fitting
• 00817770025856: MaxBlend2, High Flow 0-15 LPM DISS 50 PSI