Catalog Number

8881444015

Brand Name

Argyle

Version/Model Number

8881444015

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

-

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

df073a20-4f6d-4193-b1f4-4ce135f4f38e

Public Version Date

April 20, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

10884521002999

Quantity per Package

25

Contains DI Package

40884521002990

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK