RespArray

GUDID 06944413831988

REF:RPAYAHA01EFSBP

Edan Instruments, Inc.

General-purpose multi-parameter bedside monitor

• Primary Device ID: 06944413831988
• NIH Device Record Key: 9c6ac64b-9005-4379-80e4-faf3ed6f151c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RespArray
• Version Model Number: 83.60.262672
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	06944413831988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220308

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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: 2023-05-05
• Device Publish Date: 2023-04-27

On-Brand Devices [RespArray]

• 06944413821316: 83.60.262411
• 06944413831988: REF:RPAYAHA01EFSBP