Catalog Number

-

Brand Name

CloudCath Sensor (Sensing Hardware)

Version/Model Number

01PD001

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)

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

92c1a90d-fddc-4fee-9cd7-b3d97f6669d5

Public Version Date

August 15, 2022

Public Version Number

1

DI Record Publish Date

August 05, 2022

Package DI Number

00860006810214

Quantity per Package

1

Contains DI Package

00860006810283

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box