MAX-250

GUDID 00817770021582

MAX-250 MS Oxygen Sensor

MAXTEC, LLC

Respiratory oxygen sensor Respiratory oxygen sensor

• Primary Device ID: 00817770021582
• NIH Device Record Key: 096ca038-edd7-45e8-a1e1-1e47d28fe60d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAX-250
• Version Model Number: R125P97
• 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	00817770021582 [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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-27

On-Brand Devices [MAX-250]

• 00817770021599: MAX-250 MK Oxygen Sensor
• 00817770021582: MAX-250 MS Oxygen Sensor
• 00853061006463: Internal Oxygen Sensor with Molex Connector
• 00853061006449: Oxygen Sensor, INternal, W/ O-ring
• 00853061006418: Oxygen Sensor, Internal