MAXO2+AE INTERNATIONAL

GUDID 00817770021315

Oxygen Analyzer Ohio Medical Labeled MiniOx 200E International

MAXTEC, LLC

Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered Respiratory oxygen monitor, line-powered

• Primary Device ID: 00817770021315
• NIH Device Record Key: 495fcdd2-8abe-41f3-890d-9167b9de534f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXO2+AE INTERNATIONAL
• Version Model Number: R217P72-006
• 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	00817770021315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040484

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: 2017-02-20

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