TEExp/8-3 MHz

GUDID 00841517101152

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Oesophageal ultrasound imaging transducer, reusable

• Primary Device ID: 00841517101152
• NIH Device Record Key: 94c2fbdf-18e4-4747-9540-5e2d84af5d6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEExp/8-3 MHz
• Version Model Number: P19620-20
• 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	00841517101152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152209

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: 2016-09-15

On-Brand Devices [TEExp/8-3 MHz]

• 00841517101152: Diagnostic Ultrasound Transducer
• 00841517107116: Diagnostic Ultrasound Transducer