SEDASYS SEDARM01

GUDID 30705036003568

SEDASYS AUTOMATED RESPONSIVENESS MONITOR

ETHICON ENDO-SURGERY, INC.

Physiologic-monitoring sedation system Physiologic-monitoring sedation system

• Primary Device ID: 30705036003568
• NIH Device Record Key: 4a09ed02-a28f-41eb-9dd9-39b366755247
• Commercial Distribution Discontinuation: 2017-08-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SEDASYS
• Version Model Number: SEDARM01
• Catalog Number: SEDARM01
• Company DUNS: 123407392
• Company Name: ETHICON ENDO-SURGERY, INC.
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705036003561 [Primary]
GS1	30705036003568 [Package]; Contains: 20705036003561; Package: CASE [6 Units]; Discontinued: 2017-08-30; Not in Commercial Distribution

FDA Product Code

• PDR: Computer-assisted personalized sedation system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-17

On-Brand Devices [SEDASYS]

• 20705036010224: SEDASYS DISPLAY MONITOR
• 30705036003810: Pulse Oximeter Sensor - Finger Probe
• 30705036003803: Pulse Oximeter Sensor - Extension Cable
• 30705036003780: ECG Cable AAMI Color Std
• 30705036003773: ECG Leads AAMI Color Std
• 30705036003612: NIBP Cuff - Adult Small
• 30705036003605: NIBP Cuff - Adult Thigh
• 30705036003599: NIBP Cuff - Adult Large
• 30705036003582: NIBP Cuff - Adult
• 30705036003575: NIBP Extension
• 30705036003568: SEDASYS AUTOMATED RESPONSIVENESS MONITOR
• 30705036003551: SEDASYS UMBILICAL CABLE