Catalog Number

8888680009

Brand Name

Permcath

Version/Model Number

8888680009

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

K840424

Product Code

KNZ

Product Code Name

Accessories, a-v shunt

Public Device Record Key

025285d9-eeee-42fc-832c-77f4af0e23c3

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

April 27, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-