L38v/10-5 MHz P19360

GUDID 00841517105662

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517105662
• NIH Device Record Key: 5c349d33-3a2c-4d10-b26e-a0864750992f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L38v/10-5 MHz
• Version Model Number: P19360-15A
• Catalog Number: P19360
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517105662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180704

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2020-06-30
• Device Publish Date: 2020-06-22

On-Brand Devices [L38v/10-5 MHz]

• 00841517104047: Diagnostic Ultrasound Transducer
• 00841517102005: Diagnostic Ultrasound Transducer
• 00841517101879: Diagnostic Ultrasound Transducer
• 00841517101435: Diagnostic Ultrasound Transducer
• 00841517100889: Diagnostic Ultrasound Transducer
• 00841517105662: P19360-15A
• 00841517105174: P19360-51
• 00841517106683: Diagnostic Ultrasound Transducer
• 00841517107215: P26082-02
• 00841517108571: Diagnostic Ultrasound Transducer