DEVICE: Pall-Aquasafe™ Detachable Shower Rose (05034480314802)

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Device Identifier (DI) Information

Pall-Aquasafe™ Detachable Shower Rose
AQROSEA
AQROSEA
Pall International Sàrl
05034480314802
GS1
1
Detachable Shower Rose - For use with Pall-Aquasafe Water Filter - Faucet (AQ31F1SA) for 31 day use
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Wound irrigation nozzle A sterile device intended to be fitted to a microbial water purification filter to direct a flow of purified water for wound washing/irrigation, especially of an immunocompromised patient; it is also typically intended to assist in protecting the filter from retrograde contamination. It is typically designed as a moulded nozzle (e.g., shower rose). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
NHV SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
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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: 0.2 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
35034480314803 25 05034480314802 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

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