Catalog Number

-

Brand Name

PiCCO Catheter

Version/Model Number

PV2014L08-A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K171620,K171620,K171620

Product Code

KRB

Product Code Name

Probe, Thermodilution

Public Device Record Key

bcb4309a-ec0c-4805-840c-deb2b3214113

Public Version Date

October 13, 2021

Public Version Number

3

DI Record Publish Date

April 11, 2018

Package DI Number

24250094500959

Quantity per Package

10

Contains DI Package

14250094500952

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box