SonoSite SII P23630

GUDID 00841517103682

Diagnostic ultrasound system

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517103682
• NIH Device Record Key: c6810199-17f4-4d6f-ad9c-56175d8436b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoSite SII
• Version Model Number: P23630-14R
• Catalog Number: P23630
• 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 Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517103682 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160734

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: 2017-12-27

On-Brand Devices [SonoSite SII]

• 00841517105549: Diagnostic ultrasound system
• 00841517105532: Diagnostic ultrasound system
• 00841517105525: Diagnostic ultrasound system
• 00841517105303: Diagnostic ultrasound system
• 00841517104702: Diagnostic ultrasound system
• 00841517104580: Diagnostic ultrasound system
• 00841517104573: Diagnostic Ultrasound System
• 00841517104481: Diagnostic ultrasound system
• 00841517104474: Diagnostic ultrasound system
• 00841517104467: Diagnostic ultrasound system
• 00841517103774: SONOSITE SII ULTRASOUND SYSTEM, DTC, 1.2.1, REMANUFACTURED, ROHS
• 00841517103767: SONOSITE SII ULTRASOUND SYSTEM, STC, 1.2.1, REMANUFACTURED, ROHS
• 00841517103682: Diagnostic ultrasound system
• 00841517103675: Diagnostic ultrasound system
• 00841517103613: P23630-14
• 00841517103606: P23620-14
• 00841517103583: P20883-14
• 00841517103569: P20500-14
• 00841517102470: P23630-13
• 00841517102463: P23620-13
• 00841517102456: P23630-13R
• 00841517102449: P23620-13R
• 00841517102425: P20883-13R
• 00841517102401: Diagnostic ultrasound system
• 00841517102012: P20883-13
• 00841517101985: P20500-13
• 00841517101824: P23620-10
• 00841517101800: Diagnostic ultrasound system
• 00841517101411: P20883-12
• 00841517101398: P20500-12
• 00841517101251: P20883-10
• 00841517100216: P20500-10
• 00841517106751: P24550-41R
• 00841517106744: P24550-41
• 00841517107475: 1
• 00841517107918: SYSTEM JANUS E 4.0
• 00841517109202: P24550-45
• 00841517109172: P23620-45
• 00841517109691: Diagnostic Ultrasound Device
• 00841517109783: Diagnostic ultrasound device
• 00841517110154: Diagnostic ultrasound system