Home GUDID 30705036003803 SEDASYS
Primary DI 30705036003803
Brand SEDASYS
Company ETHICON ENDO-SURGERY, INC.
Model SEDOXEC
Catalog number SEDOXEC
Device description Pulse Oximeter Sensor - Extension Cable
Published 2016-07-15
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 30705036003803 Package GS1 50 Not in Commercial Distribution 20705036003806 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30705036003803 30705036003803 20705036003806 20705036003806
GMDN Terms# Term, Definition table Term Definition 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).
Regulatory Flags# DUNS number 123407392 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 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 10705036010203 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
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