Catalog Number

RENX-30110002

Brand Name

KidneyIntelX Blood Collection Convenience Kit

Version/Model Number

RENX-3011000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PQD

Product Code Name

Blood Specimen Collection Convenience Kit (Excludes Hiv)

Public Device Record Key

57aa23a2-7162-4808-9611-2dd2b2a28d91

Public Version Date

May 11, 2022

Public Version Number

2

DI Record Publish Date

March 25, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-