EarlySense® Contact-Free Sensor AME-00200 US

GUDID 17290016169017

EARLYSENSE LTD

Patient monitoring system module, multifunction

• Primary Device ID: 17290016169017
• NIH Device Record Key: 29727e3b-34c0-4edc-a104-db0ff519cda9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EarlySense® Contact-Free Sensor
• Version Model Number: N/A
• Catalog Number: AME-00200 US
• Company DUNS: 649822657
• Company Name: EARLYSENSE LTD
• 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: 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	07290016169010 [Primary]
GS1	17290016169017 [Package]; Contains: 07290016169010; Package: [10 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-15

Devices Manufactured by EARLYSENSE LTD

• 07290016169393 - EarlySense® InSight™: 2021-07-15
• 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
• 17290016169017 - EarlySense® Contact-Free Sensor: 2018-07-06
• 07290016169065 - EarlySense® Chair Sensor: 2018-07-06
• 07290016169140 - EarlySense® Central Display Unit: 2018-07-06