Catalog Number

IBP TS

Brand Name

MEDRAD® Imaging Bulk Package Transfer Set

Version/Model Number

IBP TS

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

-

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

K173913,K173913

Product Code

PQH

Product Code Name

Iodinated Contrast Media Transfer Tubing Set

Public Device Record Key

3a477b79-9da6-4eee-b5b7-ecbd1d76f3bd

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

August 03, 2018

Package DI Number

40616258008194

Quantity per Package

50

Contains DI Package

00616258008196

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-