L38xi/10-5 MHz Armored P19626

GUDID 00841517105648

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517105648
• NIH Device Record Key: 11d1602b-a106-4734-9f7e-e1c74dc2ad67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L38xi/10-5 MHz Armored
• Version Model Number: P19626-10A
• Catalog Number: P19626
• 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	00841517105648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162045

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 [L38xi/10-5 MHz Armored]

• 00841517100452: Diagnostic Ultrasound Transducer
• 00841517105648: P19626-10A
• 00841517107185: Diagnostic Ultrasound Transducer
• 00841517107628: P19626-20A
• 00841517109004: Diagnostic Ultrasound Transducer