RespArray ECG trunk cable

GUDID 16944413824918

Edan Instruments, Inc.

Electrocardiographic lead set, reusable

• Primary Device ID: 16944413824918
• NIH Device Record Key: 81c5062f-1a0d-4839-b74d-84ea5526ac41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RespArray ECG trunk cable
• Version Model Number: 01.57.472328
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• 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	06944413824911 [Primary]
GS1	16944413824918 [Package]; Contains: 06944413824911; Package: [10 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: 2022-09-09
• Device Publish Date: 2022-09-01

On-Brand Devices [RespArray ECG trunk cable]

• 16944413824918: 01.57.472328
• 16944413824901: 01.57.472327
• 16944413824833: 01.57.472320
• 06944413824829: 01.57.472319
• 16944413824741: 01.57.472331