DEVICE: Pall LeukoGuard BC2 (05034480306104)

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Device Identifier (DI) Information

Pall LeukoGuard BC2
BC2B
BC2B
Pall International Sàrl
05034480306104
GS1
1
Pall LeukoGuard BC2 Blood Cardioplegia Filter
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Cardiopulmonary bypass system filter, blood/cardioplegia solution A sterile, porous device intended to be incorporated into a blood/cardioplegia circuit during cardiopulmonary bypass to filter a mixture of oxygenated blood and crystalloid cardioplegia solution (e.g., 4:1 ratio) to remove/reduce potentially harmful gaseous emboli, aggregated blood constituents, particulate matter (e.g., greater than 40 microns), and leukocytes. It is typically a plastic housing with an input, output, and vent port containing a synthetic filter and leukocyte depleting media. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DTM Filter, blood, cardiopulmonary bypass, arterial line
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Reduce the level of leucocytes and exclude microemboli greater than 40 µm in size
Pore Size: 40 Micrometer
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Device Status

In Commercial Distribution
October 21, 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
35034480306105 10 05034480306104 In Commercial Distribution case
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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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)645-6578 5164843600
EURegulatory@europe.pall.com
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