Catalog Number

-

Brand Name

CARPEDIEM

Version/Model Number

IB0595570

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

DEN180055,DEN180055

Product Code

QIR

Product Code Name

Pediatric Hemodialysis System

Public Device Record Key

bf9961a3-4c2c-4cca-8916-32bea9fc4d74

Public Version Date

September 28, 2022

Public Version Number

8

DI Record Publish Date

June 17, 2020

Package DI Number

38032979792283

Quantity per Package

4

Contains DI Package

08032979792282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE