AccessGUDID - DEVICE: SEDASYS (10705036010180)

GUDID

Device Identifier (DI) Information

Brand Name: SEDASYS
Version or Model: SEDBMU01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SEDBMU01
Company Name: ETHICON ENDO-SURGERY, INC.

Primary DI Number: 10705036010180
Issuing Agency: GS1
Commercial Distribution End Date: August 30, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 123407392 *Terms of Use

Device Description: SEDASYS BEDSIDE MONITORING UNIT

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PDR	Computer-assisted personalized sedation system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4170131a-d847-497f-9948-95d72f69fa74
Public Version Date: January 10, 2023
Public Version Number: 3
DI Record Publish Date: September 17, 2014