Catalog Number

HPF300K/A

Brand Name

High Pressure Tubing, Keep™

Version/Model Number

00884450387559

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

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

FPK

Product Code Name

Tubing, fluid delivery

Public Device Record Key

8a9c5a75-ac95-42ca-b1b8-bad840766a51

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 20, 2022

Package DI Number

20884450387553

Quantity per Package

4

Contains DI Package

10884450387556

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-