Oxygen Sensor R140P07-001

GUDID 00817770022428

MAX-125M Medical Oxygen Sensor

MAXTEC, LLC

Respiratory oxygen sensor

• Primary Device ID: 00817770022428
• NIH Device Record Key: b58ca40f-d3d7-455d-a18c-da2934268e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxygen Sensor
• Version Model Number: MAX-125M
• Catalog Number: R140P07-001
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817770022428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972992

FDA Product Code

• CCL: Analyzer, Gas, Oxygen, Gaseous-Phase

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: 2020-05-13
• Device Publish Date: 2020-05-05

On-Brand Devices [Oxygen Sensor]

• 00817770022428: MAX-125M Medical Oxygen Sensor
• 00817770025719: Max-125W Oxygen Sensor
• 00817770025788: Max-125W-VME Medical Oxygen Sensor
• 00817770025641: Max-550 MaxBlend External Medical Oxygen Sensor Taiwan Labeled
• 00817770025665: Sensor, Max-250E Oxygen Taiwan