PULSOX-300i

GUDID 00817770020547

Oximeter Sleep Study without Software

MAXTEC, LLC

Pulse oximeter, battery-powered

• Primary Device ID: 00817770020547
• NIH Device Record Key: eb2f7d68-0ba0-4c53-9f29-df139c6253de
• Commercial Distribution Discontinuation: 2019-05-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PULSOX-300i
• Version Model Number: R204P18-001
• 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: true
• Serial Number: false
• 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	00817770020547 [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: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-26

On-Brand Devices [PULSOX-300i]

• 00817770021001: Oximeter Monitor
• 00817770020653: Oximeter with Soft Tip Probe
• 00817770020646: Oximeter with Spot Check Probe
• 00817770020639: Oximeter with Finger Probe
• 00817770020578: Oximeter Sleep Study with Soft Tip Probe and without Software
• 00817770020554: Oximeter Sleep Study with Soft Tip Probe
• 00817770020547: Oximeter Sleep Study without Software
• 00817770020530: Oximeter Sleep Study