MicroMax

GUDID 00853061006203

MicroMax High Flow Blender with NIST fitting

MAXTEC, LLC

Oxygen/air breathing gas mixer, hospital

• Primary Device ID: 00853061006203
• NIH Device Record Key: 2aa49c02-c900-4ef2-9095-5f5c3afeb23c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroMax
• Version Model Number: R203P14-001
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853061006203 [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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-27

On-Brand Devices [MicroMax]

• 00817770021230: MICROMAX LOW FLOW BLENDER, ARMSTONG
• 00853061006234: MicroMax High Flow Blender with DISS Fittings (Without Case.)
• 00853061006210: MIcroMax High Flow with DISS and Blender Buddy
• 00853061006203: MicroMax High Flow Blender with NIST fitting
• 00853061006166: MicroMax Low Flow NIST
• 00853061006128: MicroMax High Flow Air/Oxygen Blender with DISS Fitting
• 00853061006098: MicroMax Low Flow with Blender Buddy NIST
• 00853061006081: MicroMax Low Flow Air/Oxygen Blender with DISS Fittings and Blender Buddy
• 00853061006074: MicroMax Low Flow Air/Oxygen Blender with DISS Fitting