MAXBLEND 2

GUDID 00817770021223

MAXBLEND2, 0-3 LPM, BMD W/ DISS, 50PSI

MAXTEC, LLC

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

• Primary Device ID: 00817770021223
• NIH Device Record Key: 797c8244-b603-4d6c-809c-8b8175e8fe39
• Commercial Distribution Discontinuation: 2019-05-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MAXBLEND 2
• Version Model Number: R229P01-013
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817770021223 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-12-05

On-Brand Devices [MAXBLEND 2]

• 00817770021223: MAXBLEND2, 0-3 LPM, BMD W/ DISS, 50PSI
• 00817770021216: MAXBLEND2, 0-15 LPM, BMD W/ DISS, 50 PSI
• 00817770021100: R229P01-011
• 00817770021094: R229P01-010