DEVICE: ATR 40 Autotransfusion Reservoir (04052682000485)

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Device Identifier (DI) Information

ATR 40 Autotransfusion Reservoir
9108414
9108414
Fresenius Kabi AG
04052682000485
GS1
1
ATR 40 Reservoir is a 3 Liter collection reservoir containing a 40 µm filter, designated to collect, defoam, filter and store blood prior to processing.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Blood-processing autotransfusion system set A collection of devices designed to handle blood in the washing procedure performed by a blood-processing autotransfusion unit. The collection typically includes plastic tubing, filters (e.g., bacteria), connectors, and bags (e.g., red blood cell, waste); it may also include a disposable bowl for the processing solution (e.g., saline). The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous reinfused blood (autotransfusion). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DTN Reservoir, Blood, Cardiopulmonary Bypass
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 01, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04052682000492 8 04052682000485 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+4961726866735
sabrina.schiffer@fresenius-kabi.com
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