GUDID 06944413805620

Edan Instruments, Inc.

Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe

• Primary Device ID: 06944413805620
• NIH Device Record Key: 65dfa209-82b3-4577-aed2-803d0cd8e11a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 8MHz
• Company DUNS: 529173163
• Company Name: Edan Instruments, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413805620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140579

FDA Product Code

• HEP: Monitor, Blood-Flow, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

Devices Manufactured by Edan Instruments, Inc.

• 06944413820463 - Holter ECG and ABP System: 2023-12-08
• 06944413820470 - Holter ECG and ABP System: 2023-12-08
• 06944413820487 - Holter ECG and ABP System: 2023-12-08
• 06944413820494 - Holter ECG and ABP System: 2023-12-08
• 06944413820500 - Holter ECG and ABP System: 2023-12-08
• 06944413820562 - Electrocardiograph: 2023-12-08
• 06944413820616 - Electrocardiograph: 2023-12-08
• 06944413812680 - Ambulatory Blood Pressure Monitor: 2023-06-29