Catalog Number

SEDBMU01

Brand Name

SEDASYS

Version/Model Number

SEDBMU01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 30, 2017

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PDR

Product Code Name

Computer-assisted personalized sedation system

Public Device Record Key

4170131a-d847-497f-9948-95d72f69fa74

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 17, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-