Catalog Number

-

Brand Name

PiCCO Module

Version/Model Number

PC4510

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122121,K172259

Product Code

DXG

Product Code Name

Computer, Diagnostic, Pre-Programmed, Single-Function

Public Device Record Key

23b33c78-bf60-43be-b804-dbbf96bb544b

Public Version Date

October 13, 2021

Public Version Number

5

DI Record Publish Date

March 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-