C11n/8-5 MHz

GUDID 00841517104276

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517104276
• NIH Device Record Key: 2b7fec64-68ef-42c1-8dc7-d41a3f28fd79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C11n/8-5 MHz
• Version Model Number: P11880-80A
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517104276 [Primary]

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: 2018-12-31
• Device Publish Date: 2018-11-29

On-Brand Devices [C11n/8-5 MHz]

• 00841517104610: Diagnostic Ultrasound Transducer
• 00841517104276: Diagnostic Ultrasound Transducer
• 00841517104153: Diagnostic Ultrasound Transducer
• 00841517101220: Diagnostic Ultrasound Transducer
• 00841517100780: Diagnostic Ultrasound Transducer
• 00841517108762: Diagnostic Ultrasound Transducer