L25V/13-6 MHZ P21877

GUDID 00841517105136

TRANSDUCER, L25V 13-6 MHZ, IVIZ, REMAN

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517105136
• NIH Device Record Key: 67e53cdb-5487-44f1-8ebf-10e2daab748b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L25V/13-6 MHZ
• Version Model Number: P21877-10A
• Catalog Number: P21877
• 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: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517105136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152983

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-11
• Device Publish Date: 2019-10-03

On-Brand Devices [L25V/13-6 MHZ]

• 00841517105136: TRANSDUCER, L25V 13-6 MHZ, IVIZ, REMAN
• 00841517103804: Diagnostic ultrasound system
• 00841517105150: P21877-11
• 00841517107239: P29277-02
• 00841517108311: P21877-11A