rC60xi/5-2 MHz Armored P21636

GUDID 00841517104917

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517104917
• NIH Device Record Key: a6fdfc8b-99ac-49e1-8714-8d3b2b81033d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rC60xi/5-2 MHz Armored
• Version Model Number: P21636-20
• Catalog Number: P21636
• 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 Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517104917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162045

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: 2019-08-01
• Device Publish Date: 2019-07-24

On-Brand Devices [rC60xi/5-2 MHz Armored]

• 00841517104917: P21636-20
• 00841517100551: P21636-10A
• 00841517100544: P21636-10
• 00841517106157: P21636-20A
• 00841517107147: Diagnostic Ultrasound Transducer
• 00841517109097: Diagnostic ultrasound transducer