ATF 40 Fast start kit with AT3 - ATF 40 Fast Start Kit is a kit, consisting of - Fresenius Kabi AG

Duns Number:315654579

Device Description: ATF 40 Fast Start Kit is a kit, consisting of AT3, ATR 40 Autotransfusion reservoir and th

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More Product Details

Catalog Number

9108444

Brand Name

ATF 40 Fast start kit with AT3

Version/Model Number

9108444

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

CAC

Product Code Name

Apparatus, Autotransfusion

Device Record Status

Public Device Record Key

7082b8e6-071d-4d55-b415-c8db2cee2486

Public Version Date

March 30, 2021

Public Version Number

6

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

04052682000812

Quantity per Package

4

Contains DI Package

04052682000805

Package Discontinue Date

-

Package Status

In Commercial Distribution

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