Catalog Number

7001-3902W

Brand Name

RPC

Version/Model Number

7001-3902W

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

K852605,K852605,K852605

Product Code

FJK

Product Code Name

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Public Device Record Key

0cb998bb-a40e-4437-9a0d-1403473e7126

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

January 19, 2017

Package DI Number

20858293006001

Quantity per Package

1000

Contains DI Package

10858293006004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box