Pall-Aquasafe™ Water Filter AQF4A

GUDID 35034480313554

Disposable Shower Head Filter

Pall International Sàrl

Microbial water purification filter, non-sterilizable
Primary Device ID35034480313554
NIH Device Record Key7bdc22b1-d3d5-41cc-8740-f204b908703a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePall-Aquasafe™ Water Filter
Version Model NumberAQF4A
Catalog NumberAQF4A
Company DUNS485050483
Company NamePall International Sàrl
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)645-6578
EmailQAMedical@pall.com

Device Dimensions

Pore Size0.2 Micrometer

Device Identifiers

Device Issuing AgencyDevice ID
GS105034480313553 [Primary]
GS135034480313554 [Package]
Contains: 05034480313553
Package: case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHVSYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-20

On-Brand Devices [Pall-Aquasafe™ Water Filter]

350344803137520.2 micron Water Filter with Quick Connect Inlet and Outlet Ports for 31 day use
350344803137450.2 micron Water Filter - Faucet with Permanent Shower Spray (Rose) for 31 day use
350344803136910.2 micron Water Filter - Faucet - for 31 day use
35034480313554Disposable Shower Head Filter

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