EarlySense® InSight™ AME-02021

GUDID 07290016169393

EARLYSENSE LTD

General-purpose multi-parameter bedside monitor

• Primary Device ID: 07290016169393
• NIH Device Record Key: cc5d00a9-6cca-46f2-993e-604e33d9c8ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EarlySense® InSight™
• Version Model Number: Insight at Home
• Catalog Number: AME-02021
• Company DUNS: 649822657
• Company Name: EARLYSENSE LTD
• 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: false
• Device Combination Product: false
• 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	07290016169393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152911

FDA Product Code

• BZQ: Monitor, Breathing Frequency

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: 2021-07-15
• Device Publish Date: 2021-07-07

On-Brand Devices [EarlySense® InSight™]

• 17290016169109: N/A
• 07290016169393: Insight at Home