AMICUS Separator Life Extension Software - Software version for AMICUS Separator life - Fresenius Kabi AG

Duns Number:315654579

Device Description: Software version for AMICUS Separator life extension device

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More Product Details

Catalog Number

-

Brand Name

AMICUS Separator Life Extension Software

Version/Model Number

6.0

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200530

Product Code Details

Product Code

GKT

Product Code Name

Separator, Automated, Blood Cell, Diagnostic

Device Record Status

Public Device Record Key

f40ef89a-e0f3-462c-b102-81d5f6ee3f1c

Public Version Date

November 26, 2020

Public Version Number

1

DI Record Publish Date

November 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FRESENIUS KABI AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 87
U Unclassified 2