Catalog Number

-

Brand Name

N/A

Version/Model Number

DRPK-01

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"

Yes

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

NFK

Product Code Name

Kit, Repair, Catheter, Hemodialysis

Public Device Record Key

4d14a4fb-45ac-4a41-a45b-1e0cae385d5b

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

September 05, 2019

Package DI Number

30884908146043

Quantity per Package

5

Contains DI Package

00884908146042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX