Holter System

GUDID 06944413800960

Edan Instruments, Inc.

Electrocardiograph, professional, multichannel

• Primary Device ID: 06944413800960
• NIH Device Record Key: b24bf1b5-1d9c-4161-b345-c55047b68dac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holter System
• Version Model Number: SE-2003
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413800960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151787

FDA Product Code

• MWJ: Electrocardiograph,Ambulatory(Without Analysis)

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: 2016-09-01

On-Brand Devices [Holter System]

• 06944413800977: SE-2012
• 06944413800960: SE-2003