Catalog Number

XDS PID

Brand Name

MEDRAD® XDS Patient Interface Disposable

Version/Model Number

XDS PID

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

For Single-Use

Yes

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

8679b968-7fbf-40a9-a694-62a8f1b8e0cf

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10616258005406

Quantity per Package

100

Contains DI Package

00616258005409

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-