GUDID 06944413805583

Edan Instruments, Inc.

Foetal Doppler system probe

• Primary Device ID: 06944413805583
• NIH Device Record Key: a8ab8d7f-c5c3-456a-8db9-62c8949d4479
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2MHz
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413805583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140579

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

Devices Manufactured by Edan Instruments, Inc.

• 06944413837164 - Diagnostic Ultrasound System: 2026-03-17
• 06944413837188 - Diagnostic Ultrasound System: 2026-03-17
• 06944413837171 - Diagnostic Ultrasound System: 2026-03-17
• 06944413836532 - Diagnostic Ultrasound System: 2026-03-17
• 06944413849570 - Holter ECG and ABP System: 2026-03-10
• 06944413858664 - TOCO-MECG transducer: 2026-02-16
• 06944413858671 - TOCO-MECG transducer: 2026-02-16
• 06944413814714 - Trolley(For medical use): 2025-12-17