Oximeter

GUDID 00817770020585

Model 24 Pulse with Print Options

MAXTEC, LLC

Pulse oximeter, battery-powered

• Primary Device ID: 00817770020585
• NIH Device Record Key: a1b70da3-fa71-4007-81e9-eac04523f163
• Commercial Distribution Discontinuation: 2019-05-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Oximeter
• Version Model Number: R204P21
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817770020585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053419

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-07
• Device Publish Date: 2019-01-14

Devices Manufactured by MAXTEC, LLC

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• 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