MAX-550

GUDID 00817770020363

External Oxygen Sensor

MAXTEC, LLC

Respiratory oxygen sensor

• Primary Device ID: 00817770020363
• NIH Device Record Key: cc3e2896-5539-4e04-9a9c-64bbfd7ca615
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAX-550
• Version Model Number: R140P02
• 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	00817770020363 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-14
• Device Publish Date: 2016-09-26

On-Brand Devices [MAX-550]

• 00817770020523: External Oxygen Sensor for MaxBlend
• 00817770020363: External Oxygen Sensor