Triple Transducer Connect P16535

GUDID 00841517103941

Diagnostic Ultrasound System Accessory

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00841517103941
• NIH Device Record Key: cb7ea1a7-d178-4a71-810c-d965ac56df07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triple Transducer Connect
• Version Model Number: P16535-04
• Catalog Number: P16535
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517103941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130173

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: 2020-06-30
• Device Publish Date: 2020-06-22

On-Brand Devices [Triple Transducer Connect]

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• 00841517101619: Diagnostic Ultrasound System Accessory
• 00841517101602: Diagnostic Ultrasound System Accessory
• 00841517101596: Diagnostic Ultrasound System Accessory
• 00841517101558: Diagnostic Ultrasound System Accessory
• 00841517101541: Diagnostic Ultrasound System Accessory
• 00841517101473: Diagnostic Ultrasound System Accessory
• 00841517101466: Diagnostic Ultrasound System Accessory
• 00841517100193: Diagnostic Ultrasound System Accessory
• 00841517100186: Diagnostic Ultrasound System Accessory
• 00841517100179: Diagnostic Ultrasound System Accessory
• 00841517100148: Diagnostic Ultrasound System Accessory
• 00841517100131: Diagnostic Ultrasound System Accessory
• 00841517103941: Diagnostic Ultrasound System Accessory
• 00841517108090: Diagnostic Ultrasound System Accessory
• 00841517108175: Diagnostic Ultrasound System Accessory