L25x/13-6 MHz, armored P22950

GUDID 00841517102227

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517102227
• NIH Device Record Key: 329d270a-9f3a-42ab-9dfa-f43326a92336
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L25x/13-6 MHz, armored
• Version Model Number: P22950-10
• Catalog Number: P22950
• Company DUNS: 014438860
• Company Name: FUJIFILM SONOSITE, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xyz@xyz.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517102227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153626

FDA Product Code

• IYO: System, imaging, pulsed echo, 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: 5
• Public Version Date: 2020-02-28
• Device Publish Date: 2017-06-19

On-Brand Devices [L25x/13-6 MHz, armored]

• 00841517102272: Diagnostic Ultrasound Transducer
• 00841517102227: Diagnostic Ultrasound Transducer