EarlySense® Bedside Unit AME-00900 US

GUDID 07290016169089

EARLYSENSE LTD

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 07290016169089
• NIH Device Record Key: d5f14d52-ffea-496a-96dd-42a536541ee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EarlySense® Bedside Unit
• Version Model Number: N/A
• Catalog Number: AME-00900 US
• 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	07290016169089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131379

FDA Product Code

• BZQ: Monitor, Breathing Frequency

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-06-16

Devices Manufactured by EARLYSENSE LTD

• 07290016169393 - EarlySense® InSight™: 2021-07-15
• 07290016169089 - EarlySense® Bedside Unit: 2020-02-06
• 07290016169089 - EarlySense® Bedside Unit: 2020-02-06
• 17290016169109 - EarlySense® InSight™: 2020-02-06
• 17290016169239 - Hill-Rom® Heart and Respiration Rate Monitoring Sy: 2018-08-29
• 17290016169246 - EarlySense® BEX Sensor: 2018-08-29
• 17290016169017 - EarlySense® Contact-Free Sensor: 2018-07-06
• 07290016169065 - EarlySense® Chair Sensor: 2018-07-06
• 07290016169140 - EarlySense® Central Display Unit: 2018-07-06