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.

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• 06944413837188 - Diagnostic Ultrasound System: 2026-03-17
• 06944413837171 - Diagnostic Ultrasound System: 2026-03-17
• 06944413836532 - Diagnostic Ultrasound System: 2026-03-17
• 06944413849570 - Holter ECG and ABP System: 2026-03-10
• 06944413858664 - TOCO-MECG transducer: 2026-02-16
• 06944413858671 - TOCO-MECG transducer: 2026-02-16
• 06944413814714 - Trolley(For medical use): 2025-12-17