Catalog Number

XD 40101

Brand Name

N/A

Version/Model Number

XD 40101

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"

-

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

K161723

Product Code

PQH

Product Code Name

Iodinated contrast media transfer tubing set

Public Device Record Key

36d784ea-7b6d-4cf1-bf27-cbcaae4f7c73

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

July 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-