Catalog Number

-

Brand Name

PiCCO Monitoring Kit

Version/Model Number

PV8115CVP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2021

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"

Yes

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

K991886,K991886

Product Code

KRB

Product Code Name

Probe, Thermodilution

Public Device Record Key

b7ccdca2-0d94-4554-8352-68368232d7d7

Public Version Date

October 04, 2021

Public Version Number

5

DI Record Publish Date

March 13, 2017

Package DI Number

24250094500171

Quantity per Package

25

Contains DI Package

04250094500177

Package Discontinue Date

October 01, 2021

Package Status

Not in Commercial Distribution

Package Type

-