MINDRAY

GUDID 00817770021254

MAXTEC, LLC

Respiratory oxygen sensor Respiratory oxygen sensor

• Primary Device ID: 00817770021254
• NIH Device Record Key: 8c33fbe0-ac04-4b35-a380-e0ebf39579de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINDRAY
• Version Model Number: R115P10-011
• 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	00817770021254 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-21

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• 00817770025818 - EyeMax2: 2023-06-20 EyeMax2 Micro 20/Pack Italian (Italian Label)
• 00817770025825 - EyeMax2: 2023-06-20 EyeMax2 Preemie Italian 20/Pack (Italian Label)
• 00817770025832 - EyeMax2: 2023-06-20 EyeMax2 Regular 20/Pack (Italian Label)
• 00817770022213 - SmartStack: 2023-06-16 SmartStack Bundle
• 00817770022220 - SmartStack: 2023-06-16 SmartStack Bundle with Dual Tank Holder