RespArray ECG whole cable

GUDID 16944413825021

Edan Instruments, Inc.

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• Primary Device ID: 16944413825021
• NIH Device Record Key: 03b647c7-0693-4549-9a85-8cb427be8a65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RespArray ECG whole cable
• Version Model Number: 01.57.472343
• 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	06944413825024 [Primary]
GS1	16944413825021 [Package]; Contains: 06944413825024; 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 whole cable]

• 06944413826199: 01.57.472398
• 06944413826182: 01.57.472397
• 06944413826175: 01.57.472396
• 06944413826168: 01.57.472395
• 16944413825090: 01.57.472352
• 16944413825083: 01.57.472351
• 16944413825076: 01.57.472350
• 16944413825069: 01.57.472349
• 16944413825038: 01.57.472344
• 16944413825021: 01.57.472343
• 16944413825014: 01.57.472342
• 16944413825007: 01.57.472341
• 16944413824970: 01.57.472337
• 16944413824963: 01.57.472336
• 16944413824956: 01.57.472335
• 16944413824949: 01.57.472334
• 16944413824895: 01.57.472326
• 16944413824888: 01.57.472325
• 16944413824871: 01.57.472324
• 16944413824864: 01.57.472323