Catalog Number

PU532-8WT0

Brand Name

Spiral Coil Tubing, Trans Blue

Version/Model Number

PU532-8TD0

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MON

Product Code Name

System, Hemodialysis, Remote Accessories

Public Device Record Key

6295c92d-7e4d-48ed-98e9-af9fdc191509

Public Version Date

April 27, 2022

Public Version Number

2

DI Record Publish Date

May 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-