C60V/5-2 MHZ P21244

GUDID 00841517105167

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517105167
• NIH Device Record Key: a522bc69-c32e-45d3-ab57-5cbf3d862997
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C60V/5-2 MHZ
• Version Model Number: P21244-11
• Catalog Number: P21244
• 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 -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517105167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152983

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 [C60V/5-2 MHZ]

• 00841517103798: Diagnostic ultrasound system
• 00841517105167: P21244-11
• 00841517106690: Diagnostic Ultrasound Transducer
• 00841517107246: P29276-02