MaxBlend Lite

GUDID 00817770021780

Low Flow 3 LPM MicroMax/Precision

MAXTEC, LLC

Oxygen/air breathing gas mixer, hospital Oxygen/air breathing gas mixer, hospital

• Primary Device ID: 00817770021780
• NIH Device Record Key: 74c6511f-f61c-444e-a470-8766665f0cdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxBlend Lite
• Version Model Number: R229P03-005
• 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: 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	00817770021780 [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: 2019-02-14
• Device Publish Date: 2019-01-14

On-Brand Devices [MaxBlend Lite]

• 00817770021810: High Flow 0-70 LPM MicroMax/Precision
• 00817770021803: Low Flow 30 LPM MicroMax/Precision
• 00817770021797: Low Flow 15 LPM MicroMax/Precision
• 00817770021780: Low Flow 3 LPM MicroMax/Precision