DEVICE: SEDASYS (10705036010210)

Download: XML | JSON

Device Identifier (DI) Information

SEDASYS
SEDPSU01
SEDPSU01
ETHICON ENDO-SURGERY, INC.
10705036010210
GS1
1
SEDASYS POWER SUPPLY UNIT
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN 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).
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
PDR Computer-assisted personalized sedation system
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

Not in Commercial Distribution
September 17, 2014
August 30, 2017
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE