Ambulatory Blood Pressure Monitor

GUDID 06944413812659

Edan Instruments, Inc.

Blood pressure ambulatory recorder

• Primary Device ID: 06944413812659
• NIH Device Record Key: 856f6cf5-457e-4c28-b2a0-a602bf65ea2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambulatory Blood Pressure Monitor
• Version Model Number: SA-08
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	06944413812598 [Primary]
GS1	06944413812659 [Package]; Contains: 06944413812598; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210139

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2023-06-29
• Device Publish Date: 2023-06-21

On-Brand Devices [Ambulatory Blood Pressure Monitor]

• 06944413812673: SA-05
• 06944413812666: SA-06
• 06944413812659: SA-08
• 06944413812697: SA-09
• 06944413812680: SA-10