US Transducer

GUDID 06944413807242

Edan Instruments, Inc.

Foetal Doppler system probe

• Primary Device ID: 06944413807242
• NIH Device Record Key: a502c0cc-53a4-4039-b073-b2ee63b8624b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US Transducer
• Version Model Number: 7 ultrasound crystals, 1MHz,pink labelcable
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413807242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173042

FDA Product Code

• HGL: Transducer, Ultrasonic, Obstetric

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: 2018-11-19
• Device Publish Date: 2018-10-19

On-Brand Devices [US Transducer]

• 06944413807242: 7 ultrasound crystals, 1MHz,pink labelcable
• 06944413805491: 12 ultrasound crystals, 1MHz
• 06944413805484: 8 ultrasound crystals, 1MHz