Catalog Number

IB7010250

Brand Name

CARPEDIEM

Version/Model Number

IB7010250

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

DEN180055

Product Code

QIR

Product Code Name

Pediatric Hemodialysis System

Public Device Record Key

b853adf0-542c-47c3-b457-24cc18c4ff2f

Public Version Date

May 28, 2020

Public Version Number

1

DI Record Publish Date

May 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-