GUDID 06944413803664

Edan Instruments, Inc.

Electrocardiographic lead set, reusable

• Primary Device ID: 06944413803664
• NIH Device Record Key: c7b3135b-1f2b-4ce6-b343-1ad70e1be3fd
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Holter USB Cable
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	06944413803664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151787

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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.

• 06944413815889 - Patient Monitor: 2024-06-25
• 06944413815896 - Patient Monitor: 2024-06-25
• 06944413815902 - Patient Monitor: 2024-06-25
• 06944413813977 - ECG cable: 2024-06-06
• 06944413813984 - ECG cable: 2024-06-06
• 06944413813991 - ECG cable: 2024-06-06
• 06944413814004 - ECG cable: 2024-06-06
• 06944413814011 - ECG cable: 2024-06-06