HITACHI HEALTHCARE AMERICAS

GUDID 00869047000400

Ultrasound Transducer

HITACHI HEALTHCARE AMERICAS CORPORATION

Surgical ultrasound imaging transducer

• Primary Device ID: 00869047000400
• NIH Device Record Key: c3899464-2faa-42f5-b545-52b5496f3de1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HITACHI HEALTHCARE AMERICAS
• Version Model Number: UST-5550-R
• Company DUNS: 603156043
• Company Name: HITACHI HEALTHCARE AMERICAS 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869047000400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122537

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

[00869047000400]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-23
• Device Publish Date: 2018-07-23

On-Brand Devices [HITACHI HEALTHCARE AMERICAS]

• 00869047000424: Ultrasound Transducer
• 00869047000417: Ultrasound transducer
• 00869047000400: Ultrasound Transducer
• 00869047000448: Ultrasound transducer