Dual Lumen Extended Length Catheter - The Aquadex System is indicated for temporary (up - GAMBRO UF SOLUTIONS, INC

Duns Number:132629788

Device Description: The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.

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More Product Details

Catalog Number

114153

Brand Name

Dual Lumen Extended Length Catheter

Version/Model Number

114153

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 14, 2017

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

KDI

Product Code Name

Dialyzer, high permeability with or without sealed dialysate system

Device Record Status

Public Device Record Key

548452fa-6bd8-4210-b092-2d082e87f544

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

October 12, 2015

Additional Identifiers

Package DI Number

27332414112367

Quantity per Package

5

Contains DI Package

07332414112363

Package Discontinue Date

July 14, 2017

Package Status

Not in Commercial Distribution

Package Type

BOX

"GAMBRO UF SOLUTIONS, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 4