Catalog Number

HPF201K/A

Brand Name

High Pressure Tubing, Keep™

Version/Model Number

00884450568651

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

DXJ

Product Code Name

DISPLAY, CATHODE-RAY TUBE, MEDICAL

Public Device Record Key

32437e73-df5b-422e-874a-66f82450f201

Public Version Date

April 08, 2022

Public Version Number

1

DI Record Publish Date

March 31, 2022

Package DI Number

10884450568658

Quantity per Package

25

Contains DI Package

00884450568651

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-