Catalog Number

8817748001

Brand Name

Permcath

Version/Model Number

8817748001

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

K871942,K871942

Product Code

LFJ

Product Code Name

CATHETER, SUBCLAVIAN

Public Device Record Key

7d844810-868d-44a9-a707-8656aeb0a64c

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 22, 2014

Package DI Number

20884521009865

Quantity per Package

5

Contains DI Package

10884521009868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK