MINDRAY

GUDID 00817770021254

MAXTEC, LLC

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

Devices Manufactured by MAXTEC, LLC

• 00817770025665 - Oxygen Sensor: 2024-08-22 Sensor, Max-250E Oxygen Taiwan
• 00817770025849 - Analyzer: 2024-08-22 Analyzer, MaxO2+ A with 60 PSI BlenderBuddy
• 00817770025856 - MaxBlend2: 2024-08-22 MaxBlend2, High Flow 0-15 LPM DISS 50 PSI
• 00817770025863 - Manifold: 2024-08-22 Manifold, Acrylic 0-70 White Nist 660 PSI
• 00817770025870 - Manifold: 2024-08-22 Manifold, Acrylic 0-70 White DISS 60 PSI F&P
• 00817770025931 - Analyzer: 2024-08-22 Analyzer, MaxO2+A with Low Flow 15 LPM BlenderBuddy2
• 00817770025948 - Analyzer: 2024-08-22 Analyzer, MaxO2+ Inspirational Healthcare
• 00817770025955 - Manifold: 2024-08-22 Manifold, Acrylic 0-70 Dual Qhite Aust 60 PSI F&P