RespArray quick start kit(AHA01)

GUDID 06944413824713

Edan Instruments, Inc.

Electrocardiographic lead set, reusable

• Primary Device ID: 06944413824713
• NIH Device Record Key: f555d7fb-0bd3-4211-a552-0ad4b21dc548
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RespArray quick start kit(AHA01)
• Version Model Number: 02.01.217622
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	06944413824713 [Primary]
GS1	16944413824710 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220308

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-19
• Device Publish Date: 2022-10-11

Devices Manufactured by Edan Instruments, Inc.

• 06944413804197 - ECG Cable: 2025-09-22
• 06944413815704 - ECG Cable: 2025-09-22
• 06944413815711 - ECG Cable: 2025-09-22
• 06944413815728 - ECG Cable: 2025-09-22
• 06944413815735 - ECG Cable: 2025-09-22
• 06944413815742 - ECG Cable: 2025-09-22
• 06944413838963 - C.O. Accessories: 2025-09-22
• 06944413838406 - Patient Monitor: 2025-09-15