Home GUDID 10705036010203 SEDASYS
Primary DI 10705036010203
Brand SEDASYS
Company ETHICON ENDO-SURGERY, INC.
Model SEDPRU01
Catalog number SEDPRU01
Device description SEDASYS CONTROL UNIT
Published 2014-09-17
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name PDR Computer-assisted personalized sedation system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PDR Computer-Assisted Personalized Sedation System Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10705036010203 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10705036010203 10705036010203
GMDN Terms# Term, Definition table Term Definition 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).
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 20 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 123407392 Device count 1 Serial number true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 20705036003578 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 20705036003585 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 20705036003592 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 20705036003608 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 20705036003615 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 20705036003776 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 20705036003783 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 20705036003806 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 20705036003813 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 30705036003575 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 30705036003582 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 30705036003599 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 30705036003605 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 30705036003612 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 30705036003773 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 30705036003780 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 30705036003803 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 30705036003810 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2016-07-15 10705036003434 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2014-09-17 10705036010180 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2014-09-17 10705036010210 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2014-09-17 20705036003554 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2014-09-17 20705036003561 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2014-09-17 30705036003551 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2014-09-17 30705036003568 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2014-09-17 20705036010224 SEDASYS ETHICON ENDO-SURGERY, INC. PDR 2014-09-17