DEVICE: Pall (05034480315106)

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Device Identifier (DI) Information

Pall
6254185
6254185
Pall International Sàrl
05034480315106
GS1
1
Transducer Protector Hydrophobic Vent Filter (female and male slip luer)
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Haemodialysis system transducer protector A sterile device designed to protect a haemodialysis system pressure monitor and to help maintain the sterility of the blood tubing fluid pathway. It is typically attached between the blood tubing set and the pressure monitor and typically consists of plastic housing that contains a hydrophobic filter with a reference pore size (e.g., 1 to 2 microns) that helps prevent cross-contamination by viruses, bacteria, and particulate matter while preventing the flow of fluids to the pressure monitor. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FIB PROTECTOR, TRANSDUCER, DIALYSIS
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Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Pore Size: 0.2 Micrometer
Device Size Text, specify: Hydrophobic 0.2 µm Versapor® membrane
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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
35034480315107 50 05034480315106 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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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