Catalog Number

-

Brand Name

PiCCO Catheter

Version/Model Number

PV2015L20N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 12, 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

K072364,K072364,K072364

Product Code

KRB

Product Code Name

Probe, Thermodilution

Public Device Record Key

5cf5ea5e-491a-4d3d-be21-5227b6690c30

Public Version Date

October 13, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

24250094500676

Quantity per Package

10

Contains DI Package

14250094500679

Package Discontinue Date

October 12, 2021

Package Status

Not in Commercial Distribution

Package Type

Box