Catalog Number

8888509703

Brand Name

Argyle

Version/Model Number

8888509703

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

f4d18a13-6e83-4581-bec1-920059ae3972

Public Version Date

April 20, 2020

Public Version Number

7

DI Record Publish Date

February 01, 2017

Package DI Number

20884521101774

Quantity per Package

50

Contains DI Package

00884521150990

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE