Catalog Number

197560

Brand Name

Argo Bagz Fluid Management Systems

Version/Model Number

197560

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

K904994,K904994

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Public Device Record Key

b93f3b31-9e79-45b4-9de7-fb318e2eaee0

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 08, 2016

Package DI Number

20886333208740

Quantity per Package

20

Contains DI Package

00886333208746

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box