Catalog Number

-

Brand Name

Argyle

Version/Model Number

8818782001

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

-

Product Code

LFJ

Product Code Name

CATHETER, SUBCLAVIAN

Public Device Record Key

f955b8fd-d77c-47d5-9d38-68e25c7b2e42

Public Version Date

March 16, 2022

Public Version Number

4

DI Record Publish Date

October 22, 2015

Package DI Number

10884521009981

Quantity per Package

25

Contains DI Package

20884521009988

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CT