MaxBlend2 R229P02-101

GUDID 00817770025672

MaxBlend2 High Flow 0-70 LPM Flowmeter DISS Fitting

MAXTEC, LLC

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• Primary Device ID: 00817770025672
• NIH Device Record Key: a14f2e08-da92-44c1-ae12-a1d408e7ca35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxBlend2
• Version Model Number: High Flow
• Catalog Number: R229P02-101
• 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	00817770025672 [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: 2023-06-16
• Device Publish Date: 2023-06-08

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