SonoSite M-Turbo P28965

GUDID 00841517105747

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517105747
• NIH Device Record Key: a43627d9-d6c6-4d08-8986-02f03b12a9eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoSite M-Turbo
• Version Model Number: P28965-25
• Catalog Number: P28965
• 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 Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517105747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101757

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: 2020-05-05
• Device Publish Date: 2020-04-27

On-Brand Devices [SonoSite M-Turbo]

• 00841517104788: Diagnostic ultrasound system
• 00841517104771: Diagnostic ultrasound system
• 00841517104764: Diagnostic ultrasound system
• 00841517104757: Diagnostic ultrasound system
• 00841517104665: Diagnostic ultrasound system
• 00841517104559: P17000-18R
• 00841517104542: P17000-18C
• 00841517104498: Diagnostic Ultrasound System
• 00841517103231: P17000-13R
• 00841517103224: P17000-13C
• 00841517103057: P08189-87R
• 00841517103040: P08189-86R
• 00841517103033: P08189-85R
• 00841517103026: P08189-84R
• 00841517103019: P08189-83R
• 00841517103002: P08189-82R
• 00841517102999: P08189-80R
• 00841517102982: P08189-77R
• 00841517102975: P08189-32R
• 00841517102739: P17000-13Â
• 00841517102609: P08189-87Â
• 00841517102593: P08189-82Â
• 00841517101961: M-TURBO ULTRASOUND SYSTEM, 1.9.2, REMANUFACTURED, ROHS
• 00841517101954: M-TURBO ULTRASOUND SYSTEM, 1.9.2, ROHS
• 00841517101947: M-TURBO ULTRASOUND SYSTEM, 1.9.2, ROHS
• 00841517101930: M-TURBO ULTRASOUND SYSTEM, 1.9.2, REMANUFACTURED
• 00841517101923: M-TURBO ULTRASOUND SYSTEM, 1.9.2
• 00841517101732: P17000-16
• 00841517101688: M-TURBO ULTRASOUND SYSTEM, 1.9.2
• 00841517101299: P08189-88R
• 00841517101282: P08189-88
• 00841517100261: P17000-15C
• 00841517100254: P17000-15R
• 00841517100032: Diagnostic ultrasound system
• 00841517105747: P28965-25
• 00841517105709: P28965-25C
• 00841517105693: P28965-25R
• 00841517107437: 1
• 00841517107833: M-TURBO ULTRASOUND SYSTEM, 3.0
• 00841517107895: M-TURBO ULTRASOUND SYSTEM, 3.0
• 00841517109189: P17000-45
• 00841517109769: diagnostic ultrasound system
• 00841517109721: Diagnostic Ultrasound system