rP19xp/5-1 MH P22557

GUDID 00841517101589

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517101589
• NIH Device Record Key: 07fbdd80-922b-49b5-8c7f-d148a499ce01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rP19xp/5-1 MH
• Version Model Number: P22557-10
• Catalog Number: P22557
• 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

• Handling Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517101589 [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: 2017-03-01

On-Brand Devices [rP19xp/5-1 MH]

• 00841517105600: TRANSDUCER, RP19XP/5-1 MHZ, ROHS, CHINA
• 00841517101886: TRANSDUCER, RP19XP/5-1 MHZ, ROHS REMAN
• 00841517101589: Diagnostic Ultrasound Transducer
• 00841517109530: Diagnostic ultrasound transducer