L38E/10-5 MHZ P05482

GUDID 00841517102838

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517102838
• NIH Device Record Key: 22b1e17b-d13e-46f3-aab8-e6d835f59aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L38E/10-5 MHZ
• Version Model Number: P05482-26A
• Catalog Number: P05482
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517102838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053069

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-24

On-Brand Devices [L38E/10-5 MHZ]

• 00841517104016: P05482-30
• 00841517104009: P05482-26
• 00841517103422: TRANSDUCER, L38E/10-5 MHZ, ROHS, REMAN
• 00841517103279: TRANSDUCER, L38E/10-5 MHZ, ROHS
• 00841517103262: TRANSDUCER, L38E/10-5 MHZ, ROHS
• 00841517102838: P05482-26A
• 00841517102555: P05482-71Â
• 00841517101664: TRANSDUCER, L38E/10-5 MHZ, ROHS, REMAN
• 00841517101183: P05482-30A