Easy@Home Fingertip Pulse Oximeter

GUDID 10810038630004

EASY HEALTHCARE CORPORATION

Pulse oximeter, battery-powered

• Primary Device ID: 10810038630004
• NIH Device Record Key: 296a22c6-a4e7-43e7-ae1c-cfaa09141182
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Fingertip Pulse Oximeter
• Version Model Number: EHP035
• 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	00810038630007 [Primary]
GS1	10810038630004 [Package]; Contains: 00810038630007; Package: Carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161560

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-11
• Device Publish Date: 2020-02-03

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

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