Triple Transducer Connect P15922

GUDID 00841517101602

Diagnostic Ultrasound System Accessory

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517101602
• NIH Device Record Key: 3ebaf26c-1d00-49b7-9548-1df92d892049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triple Transducer Connect
• Version Model Number: P15922-16R
• Catalog Number: P15922
• 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

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517101602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043452

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: 2016-10-21

On-Brand Devices [Triple Transducer Connect]

• 00841517102104: Diagnostic Ultrasound System Accessory
• 00841517101626: Diagnostic Ultrasound System Accessory
• 00841517101619: Diagnostic Ultrasound System Accessory
• 00841517101602: Diagnostic Ultrasound System Accessory
• 00841517101596: Diagnostic Ultrasound System Accessory
• 00841517101558: Diagnostic Ultrasound System Accessory
• 00841517101541: Diagnostic Ultrasound System Accessory
• 00841517101473: Diagnostic Ultrasound System Accessory
• 00841517101466: Diagnostic Ultrasound System Accessory
• 00841517100193: Diagnostic Ultrasound System Accessory
• 00841517100186: Diagnostic Ultrasound System Accessory
• 00841517100179: Diagnostic Ultrasound System Accessory
• 00841517100148: Diagnostic Ultrasound System Accessory
• 00841517100131: Diagnostic Ultrasound System Accessory
• 00841517103941: Diagnostic Ultrasound System Accessory
• 00841517108090: Diagnostic Ultrasound System Accessory
• 00841517108175: Diagnostic Ultrasound System Accessory
• 00841517110352: Diagnostic Ultrasound System Accessory
• 00841517110345: Diagnostic Ultrasound System Accessory