SonoSite Edge P28961

GUDID 00841517105754

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517105754
• NIH Device Record Key: e67ca124-7a68-480c-bfbc-a1508b372f09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoSite Edge
• Version Model Number: P28961-68R
• Catalog Number: P28961
• 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

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517105754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113156

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-05
• Device Publish Date: 2020-04-27

On-Brand Devices [SonoSite Edge]

• 00841517103897: P15000-67R
• 00841517103217: P15000-63R
• 00841517103200: P15000-18R
• 00841517103194: P15000-15R
• 00841517103187: P15000-14R
• 00841517103170: P15000-13R
• 00841517103163: P15000-12R
• 00841517102678: P15000-63
• 00841517102661: P15000-60
• 00841517102654: P15000-18
• 00841517102647: P15000-15
• 00841517102517: P15000-21R
• 00841517102500: P15000-21
• 00841517102098: P15000-67
• 00841517101770: P15000-66R
• 00841517101763: P15000-20R
• 00841517101725: P15000-66
• 00841517101718: P15000-20
• 00841517101381: P15000-19R
• 00841517101374: P15000-19
• 00841517100247: P15000-64R
• 00841517100230: P15000-64
• 00841517105754: P28961-68R
• 00841517105723: P28961-68
• 00841517105457: P15000-22
• 00841517105440: P15000-22R
• 00841517105433: P15000-68
• 00841517105426: P15000-68R
• 00841517107925: SONOSITE EDGE II ULTRASOUND SYSTEM, INDIA