RespArray ECG limb cable

GUDID 16944413824840

Edan Instruments, Inc.

Electrocardiographic lead set, reusable

• Primary Device ID: 16944413824840
• NIH Device Record Key: b86d4094-f671-41f4-91e8-86e68f2c36c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RespArray ECG limb cable
• Version Model Number: 01.57.472321
• 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	06944413824843 [Primary]
GS1	16944413824840 [Package]; Contains: 06944413824843; 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 limb cable]

• 16944413825052: 01.57.472346
• 16944413825045: 01.57.472345
• 16944413824994: 01.57.472340
• 16944413824987: 01.57.472339
• 16944413824932: 01.57.472330
• 16944413824925: 01.57.472329
• 16944413824857: 01.57.472322
• 16944413824840: 01.57.472321
• 16944413824796: 01.57.472348
• 16944413824789: 01.57.472347
• 16944413824765: 01.57.472333
• 16944413824758: 01.57.472332