Sweetiesong Fetal Doppler

GUDID 00850253007086

EASY HEALTHCARE CORPORATION

Foetal Doppler system

• Primary Device ID: 00850253007086
• NIH Device Record Key: 3e0ea882-e22c-44a0-8475-e4267260b040
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sweetiesong Fetal Doppler
• Version Model Number: EZD-100S5
• 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: true
• 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	00850253007086 [Primary]
GS1	10850253007083 [Package]; Package: [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131457

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

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: 2019-06-24
• Device Publish Date: 2016-08-01

On-Brand Devices [Sweetiesong Fetal Doppler]

• 00850253007093: EZD-100S6
• 00850253007086: EZD-100S5