Catalog Number

SEDE3AMI

Brand Name

SEDASYS

Version/Model Number

SEDE3AMI

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 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

7372bceb-f532-4d3b-80e5-96c3eae41b2d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 15, 2016

Package DI Number

30705036003773

Quantity per Package

50

Contains DI Package

20705036003776

Package Discontinue Date

June 15, 2017

Package Status

Not in Commercial Distribution

Package Type

CASE