Argo Bagz Fluid Management System - Argo Bagz Fluid Management System - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Argo Bagz Fluid Management System

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

197530

Brand Name

Argo Bagz Fluid Management System

Version/Model Number

197530

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Device Record Status

Public Device Record Key

da329021-c1e6-4a2b-8c9d-6b9f4cb469d8

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 10, 2016

Additional Identifiers

Package DI Number

20886333208696

Quantity per Package

20

Contains DI Package

00886333208692

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205