SEDASYS

Basic Information

• Brand Name: SEDASYS
• Primary DI: 20705036003561
• Version / Model: SEDARM01
• Catalog Number: SEDARM01
• Company Name: ETHICON ENDO-SURGERY, INC.
• Labeler DUNS: 123407392
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-17
• Public Version: 3
• Public Version Date: 2023-01-10
• Public Version Status: Update
• Public Device Record Key: 4a09ed02-a28f-41eb-9dd9-39b366755247
• Distribution End Date: 2017-08-30

Device Description

SEDASYS AUTOMATED RESPONSIVENESS MONITOR

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PDR	Computer-assisted personalized sedation system	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46924	Intraprocedural physiologic-monitoring sedation system	An assembly of devices designed to monitor patient physiology while delivering a sedative agent intravenously during a diagnostic or surgical procedure (e.g., endoscopy, minor plastic surgery, cardiovascular procedure). It is a computer-assisted personalized sedation (CAPS) system that typically consists of physiologic/responsiveness monitors [e.g., for blood pressure, oxygen (O2) saturation, capnometry], an infusion pump, an O2 delivery module, alarms, controls, and a computer with software that integrates the components to react to the patient's physiology for precisely controlled sedation. It may contain batteries to facilitate use during transport (e.g., from bedside to procedure room).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30705036003568	GS1	CASE	6	Not in Commercial Distribution	2017-08-30
Primary	20705036003561	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity