SmartUs

GUDID 04772057000192

Ultrasound transducer phased array

TELEMED UAB

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 04772057000192
• NIH Device Record Key: fba4b52c-1081-4b5b-af62-2fc1922f7256
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartUs
• Version Model Number: P5-1L15SI-6
• Company DUNS: 366590052
• Company Name: TELEMED UAB
• 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: +37052106272
• Email: support@telemed.lt

Device Identifiers

Device Issuing Agency	Device ID
GS1	04772057000192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163121

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: 2017-09-04

On-Brand Devices [SmartUs ]

• 04772057000246: Ultrasound transducer linear array 30mm
• 04772057000239: Ultrasound transducer linear array 25mm
• 04772057000222: Ultrasound transducer linear array 40mm
• 04772057000208: Ultrasound transducer linear array 40mm
• 04772057000192: Ultrasound transducer phased array
• 04772057000178: Ultrasound transducer convex array
• 04772057000161: Ultrasound system, imaging, general-purpose, portable
• 04772057000154: Ultrasound system, imaging, general-purpose, portable