Catalog Number

7001-3926

Brand Name

RPC

Version/Model Number

7001-3926

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

K855039,K855039,K855039

Product Code

GCE

Product Code Name

Adaptor, Catheter

Public Device Record Key

b2216e32-857a-4699-9d23-9a9d6a84e859

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

March 07, 2017

Package DI Number

20858293006018

Quantity per Package

1000

Contains DI Package

00858293006014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

package