DEVICE: Gardian 25 mm Syringe Filter (05034480315472)

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Device Identifier (DI) Information

Gardian 25 mm Syringe Filter
6094184
6094184
Pall International Sàrl
05034480315472
GS1
50
25mm syringe filter with 5.0 micron low protein binding Versapor® membrane
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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
Syringe filter, clinical A sterile membrane intended to be used in a syringe or connected to a syringe (e.g., between the syringe and the needle or cannula) to sterilize, ultraclean, or clarify medicinal solutions during pharmaceutical preparation or patient injection. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FPB Filter, infusion line
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Pore Size: 5 Micrometer
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Device Status

In Commercial Distribution
July 20, 2016

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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
No Package DIs found
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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: 25034480315476 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

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+1(800)645-6578 5164843600
QAMedical@pall.com
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