Areta Fingertip Pulse Oximeter

GUDID 00850253007109

EASY HEALTHCARE CORPORATION

Telemetric pulse oximeter

• Primary Device ID: 00850253007109
• NIH Device Record Key: 87518235-cf96-4483-89de-1125893c95b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Areta Fingertip Pulse Oximeter
• Version Model Number: EZD-500A
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850253007109 [Primary]
GS1	10850253007106 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140582

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: 4
• Public Version Date: 2018-11-26
• Device Publish Date: 2016-08-01

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