Catalog Number

680059

Brand Name

CRITICATH(TM) SP5337H MONITORING CATHETER

Version/Model Number

680059

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)

Yes

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

-

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

c6559ab2-d8fe-4578-b35f-4b51de3b4224

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

50886333600590

Quantity per Package

20

Contains DI Package

00886333600595

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek tray