Catalog Number

197822

Brand Name

Pressure Monitoring Line Neonatal 72"(183cm) M/F PVC

Version/Model Number

197822

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

87f98571-e777-4ff1-9ca1-40a354abf13d

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

August 18, 2016

Package DI Number

20886333208948

Quantity per Package

25

Contains DI Package

00886333208944

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box