Catalog Number

-

Brand Name

Tubing, Extension Line, Yellow for Pura, 150 cm

Version/Model Number

TUBEX1Y

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FEN

Product Code Name

DEVICE, CYSTOMETRIC, HYDRAULIC

Public Device Record Key

0028772f-c44e-47cf-bd36-a2f174026b41

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

October 01, 2017

Package DI Number

30627825010390

Quantity per Package

60

Contains DI Package

20627825010393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-