Catalog Number

TAG C50 HPCT

Brand Name

MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 50cm (20in)

Version/Model Number

TAG C50 HPCT

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

K131517,K131517

Product Code

FPK

Product Code Name

Tubing, Fluid Delivery

Public Device Record Key

953f21bf-2ff7-474b-9864-88a4811e31d4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10616258006960

Quantity per Package

25

Contains DI Package

00616258006963

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-