MAX-250A

GUDID 00817770021438

Oxygen Sensor w/o Adapter, MAX-250A

MAXTEC, LLC

Respiratory oxygen sensor

• Primary Device ID: 00817770021438
• NIH Device Record Key: 6094e2be-7e85-40bd-a86c-acf4f773010a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAX-250A
• Version Model Number: R125P04-003
• 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	00817770021438 [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-250A]

• 00817770021438: Oxygen Sensor w/o Adapter, MAX-250A
• 00853061006524: Oxygen Sensor with External Phone Jack