Duns Number:140727624
Device Description: Argo Bagz Fluid Management System
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
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
da329021-c1e6-4a2b-8c9d-6b9f4cb469d8
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 10, 2016
Package DI Number
20886333208696
Quantity per Package
20
Contains DI Package
00886333208692
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
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 |