US Transducer

GUDID 06944413807242

Edan Instruments, Inc.

Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe 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