Doppler-Box X 7750

GUDID 04260493310055

Ultrasound Doppler Device

Compumedics Germany GmbH

Noninvasive vascular ultrasound system, line-powered

• Primary Device ID: 04260493310055
• NIH Device Record Key: ed3b7a05-a65e-49fb-8dd3-6f980da6b022
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Doppler-Box X
• Version Model Number: DBX
• Catalog Number: 7750
• Company DUNS: 344791632
• Company Name: Compumedics Germany GmbH
• 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

Customer Support Contacts

• Phone: +1 888 757 5351
• Email: info@dwl.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260493310055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051085

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

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: 2016-07-28

On-Brand Devices [Doppler-Box X]

• 04260493310765: Ultrasound Doppler Device (Doppler-Box X1)
• 04260493310055: Ultrasound Doppler Device