DEVICE: Pall QPoint® Filter Capsule (05034480315502)

Device Identifier (DI) Information

Pall QPoint® Filter Capsule
QJ22A
In Commercial Distribution
QJ22A
Pall International Sàrl
05034480315502
GS1

1
485050483 *Terms of Use
Pall QPoint® Filter Capsule, Water Filter Capsule for Faucets
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58088 Microbial water purification filter, non-sterilizable
A sterile device designed to remove bacteria and other suspended particles from flowing water by creating a mechanical barrier to elements larger than 0.2 micrometres. It typically consists of a plastic housing with a connector to the water source [e.g., a tap (faucet)] and a 0.2 micrometre filtering membrane [e.g., made of nylon, polyvinylidene fluoride (PVDF), or polyethersulfone (PES)]; a prefiltration of the water to remove larger particles is typically recommended. It is typically used for hygienic and surgical hand washing, wound irrigation, and/or rinsing of medical devices. This is a disposable, non-sterilizable device which may serve multiple patients before being discarded.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NHV SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K163609 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Device Record Status

3e9d966f-e050-426e-a229-3763fb128743
September 06, 2018
4
December 20, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
35034480315503 2 05034480315502 In Commercial Distribution case
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Secondary DI

[?]
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
QAMedical@pall.com
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