Catalog Number

8888570564

Brand Name

Argyle

Version/Model Number

8888570564

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

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

16ce7fa6-3381-402f-9b37-acfdae301f0b

Public Version Date

March 08, 2022

Public Version Number

5

DI Record Publish Date

May 09, 2017

Package DI Number

00884521060879

Quantity per Package

10

Contains DI Package

00884521149529

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE