Catalog Number

-

Brand Name

CloudCath Drain Set - Baxter Configuration

Version/Model Number

02PD001

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

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

-

Product Code

FKX

Product Code Name

System, Peritoneal, Automatic Delivery

Public Device Record Key

b09907b3-0919-4ab0-b4a5-be127aa7a869

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 12, 2022

Package DI Number

00860006810221

Quantity per Package

30

Contains DI Package

00860006810207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box