MAX-250+

GUDID 00817770021247

MAX-250+ Oxygen Sensor Drive Medical

MAXTEC, LLC

Respiratory oxygen sensor

• Primary Device ID: 00817770021247
• NIH Device Record Key: f40571c4-5364-4ba3-9f4f-c701c351f196
• Commercial Distribution Discontinuation: 2019-05-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MAX-250+
• Version Model Number: R125P02-014
• 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	00817770021247 [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: 2019-05-07
• Device Publish Date: 2016-12-15

On-Brand Devices [MAX-250+ ]

• 00817770021247: MAX-250+ Oxygen Sensor Drive Medical
• 00853061006470: Internal Medical Oxygen Sensor