PHOENIX - Phoenix is a self-contained, - GAMBRO DASCO SPA

Duns Number:428788780

Device Description: Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies.

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More Product Details

Catalog Number

103453

Brand Name

PHOENIX

Version/Model Number

6023006700

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

-

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

003265a8-b239-4fba-8dfa-39bd9edc1f09

Public Version Date

December 31, 2021

Public Version Number

9

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GAMBRO DASCO SPA" 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. 9