Holter ECG and ABP System

GUDID 06944413820470

Edan Instruments, Inc.

Electrocardiographic ambulatory recorder

• Primary Device ID: 06944413820470
• NIH Device Record Key: d66e9218-b19a-41b1-8b4b-4cac7da92679
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holter ECG and ABP System
• Version Model Number: SA-16
• 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	06944413820470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230184

FDA Product Code

• DSH: Recorder, Magnetic Tape, Medical

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: 2023-12-08
• Device Publish Date: 2023-11-30

On-Brand Devices [Holter ECG and ABP System]

• 06944413820500: SA-20
• 06944413820494: SA-19
• 06944413820487: SA-18
• 06944413820470: SA-16
• 06944413820463: SA-15