Catalog Number

PM6012/B

Brand Name

Pressure Monitor Tubing

Version/Model Number

00884450569252

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

dbba3857-f603-4e88-8810-cb449ba29c26

Public Version Date

April 18, 2022

Public Version Number

1

DI Record Publish Date

April 09, 2022

Package DI Number

20884450569256

Quantity per Package

4

Contains DI Package

10884450569259

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-