Catalog Number

-

Brand Name

PiCCO Catheter

Version/Model Number

PV2015L20-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

690432bf-2341-4878-b665-d21c6e6147ac

Public Version Date

October 13, 2021

Public Version Number

3

DI Record Publish Date

April 06, 2018

Package DI Number

14250094500938

Quantity per Package

5

Contains DI Package

04250094500931

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box