Pall QPoint® Disposable Water Filter

Primary DI
05034480315663
Brand
Pall QPoint® Disposable Water Filter
Company
Global Life Sciences Solutions USA LLC
Model
QJC22A
Device description
Pall QPoint® Disposable Water Filter for Faucets
Published
2019-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHVSystem, Water Purification, General Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHVSystem, Water Purification, General Medical UseGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163609000Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)Pall International Sarl2017-06-01NHV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35034480315664PackageGS12In Commercial Distribution
05034480315663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3503448031566435034480315664
05034480315663050344803156635034480315663

GMDN Terms#

Term, Definition table
TermDefinition
Microbial water purification filter, non-sterilizableA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
516-801-9267regulatoryaffairs@pall.com

Regulatory Flags#

DUNS number
011658242
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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Primary DI, Brand, Company table
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