Digi-One

GUDID 07290016734027

The Digi-One System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in c

RIMED LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 07290016734027
• NIH Device Record Key: 7ccfc9c6-a4a7-4f87-ad07-95d8e17e09a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digi-One
• Version Model Number: Digi-One
• Company DUNS: 600054688
• Company Name: RIMED LTD.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016734027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143476

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, 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: 2016-09-24

Devices Manufactured by RIMED LTD.

• 07290016734003 - Digi-Lite: 2018-07-06 The Digi-Lite System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregulari
• 07290016734010 - Digi-Lite IP: 2018-07-06 The Digi-Lite IP color flow imaging system is an ultrasound based system intended for use in non-invasive vascular evaluation fo
• 07290016734027 - Digi-One: 2018-07-06The Digi-One System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in c
• 07290016734027 - Digi-One: 2018-07-06 The Digi-One System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularit
• 07290016734034 - Digi-Lite IP Linear Probe: 2018-07-06 The Digi-Lite IP Linear Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and i
• 07290016734041 - PW 2MHz Ultrasonic Probe: 2018-07-06 The PW 2MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and in
• 07290016734058 - CW 4MHz Ultrasonic Probe: 2018-07-06 CW 4MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intend
• 07290016734065 - CW 8MHz Ultrasonic Probe: 2018-07-06 The CW 8MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and in