SEDASYS SEDE3AMI

GUDID 30705036003773

ECG Leads AAMI Color Std

ETHICON ENDO-SURGERY, INC.

Physiologic-monitoring sedation system

• Primary Device ID: 30705036003773
• NIH Device Record Key: 7372bceb-f532-4d3b-80e5-96c3eae41b2d
• Commercial Distribution Discontinuation: 2017-06-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SEDASYS
• Version Model Number: SEDE3AMI
• Catalog Number: SEDE3AMI
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: +1(800)733-2797
• Email: sedasystechsupport@its.jnj.com
• Phone: +1(800)733-2797
• Email: sedasystechsupport@its.jnj.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705036003776 [Primary]
GS1	30705036003773 [Package]; Contains: 20705036003776; Package: CASE [50 Units]; Discontinued: 2017-06-15; 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: 2016-07-15

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