SonoSite S-Series P09417

GUDID 00841517103095

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517103095
• NIH Device Record Key: e7dddcd4-52fd-407b-b892-62da0a7eadac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoSite S-Series
• Version Model Number: P09417-67R
• Catalog Number: P09417
• 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 Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517103095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130173

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

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: 2017-10-24

On-Brand Devices [SonoSite S-Series]

• 00841517105495: P09417-71R
• 00841517105488: P09417-95R
• 00841517103101: P09417-68R
• 00841517103095: P09417-67R
• 00841517103088: P09417-66R
• 00841517103071: P09417-65R
• 00841517103064: P09417-57R
• 00841517102623: P09417-92
• 00841517102616: P09417-68
• 00841517101794: P09417-94R
• 00841517101787: P09417-70R
• 00841517101701: P09417-94
• 00841517101695: SONOSITE S SERIES ULTRASOUND SYSTEM, S1.9.2
• 00841517101312: P09417-69R
• 00841517101305: P09417-69
• 00841517100285: P09417-93R
• 00841517100278: P09417-93
• 00841517105730: P28962-95
• 00841517105716: P28962-95R