Easy@Home Fingertip Pulse Oximeter

GUDID 00850253007116

EASY HEALTHCARE CORPORATION

Telemetric pulse oximeter

• Primary Device ID: 00850253007116
• NIH Device Record Key: 3eeab0d5-7117-406c-985f-1c863889da82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Fingertip Pulse Oximeter
• Version Model Number: EHP50D1
• 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	00850253007116 [Primary]
GS1	10850253007113 [Package]; Package: [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082641

FDA Product Code

• DQA: Oximeter
• OCH: Oximeter, Infrared, Sporting, Aviation

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: 2019-06-14
• Device Publish Date: 2016-08-01

On-Brand Devices [Easy@Home Fingertip Pulse Oximeter]

• 00850253007116: EHP50D1
• 00850003180199: EHP50D1
• 10810038630004: EHP035
• 10810038631087: EHP029