Catalog Number

8888513200

Brand Name

Argyle

Version/Model Number

8888513200

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KGZ

Product Code Name

ACCESSORIES, CATHETER

Public Device Record Key

1458af24-305d-4fc1-929a-1db6fd028f35

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

June 27, 2018

Package DI Number

00884521071356

Quantity per Package

50

Contains DI Package

00884521149093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE