Catalog Number

040206105A

Brand Name

Pressure Monitoring Line

Version/Model Number

040206105A

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K781558,K781558

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

22f7e7a7-1775-4cee-ae0c-397523323d83

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

20886333201222

Quantity per Package

25

Contains DI Package

00886333201228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box