FDA.reportPublic FDA data

Pall QPoint® Filter Capsule

Primary DI
35034480315503
Brand
Pall QPoint® Filter Capsule
Company
Pall International Sàrl
Model
QJ22A
Catalog number
QJ22A
Device description
Pall QPoint® Filter Capsule, Water Filter Capsule for Faucets
Published
2017-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
35034480315503PackageGS12In Commercial Distribution
05034480315502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3503448031550335034480315503
05034480315502050344803155025034480315502

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pore Size0.2Micrometer

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)645-6578QAMedical@pall.com

Regulatory Flags#

DUNS number
485050483
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05034480310125Pall PharmAssure® 25 mm Hydrophobic Vent FilterHP2002HP20022016-07-27
05034480000392Pall LeukoGuard LGLG6LG62015-10-21
05034480000408Pall LeukoGuard LGLG6BLG6B2015-10-21
05034480000446Pall® Oxygenator Gas Line FilterORO1HORO1H2016-07-20
05034480104373Pall Supor® AEF FilterAEF1EAEF1E2016-07-20
05034480306104Pall LeukoGuard BC2BC2BBC2B2015-10-21
05034480308825Pall Supor® AEF FilterAEF1NTEAEF1NTE2016-07-20
05034480308979Pall LaparoShield® Plus Laparoscopic Smoke Filtration SystemLSF1LSF12016-07-20
05034480309143Pall® Pro-Tec Filter for Pulmonary Function TestingPF30SPF30S2016-07-20
05034480310170Pall PharmAssure® Syringe FilterHP4648HP46482024-03-15
05034480313553Pall-Aquasafe™ Water FilterAQF4AAQF4A2016-07-20
05034480313690Pall-Aquasafe™ Water FilterAQ31F1SAAQ31F1SA2016-07-20
05034480313744Pall-Aquasafe™ Water FilterAQ31F1RAAQ31F1RA2016-07-20
05034480313751Pall-Aquasafe™ Water FilterAQINAAQINA2016-07-20
05034480314147Pall LaparoShield® Plus Laparoscopic Smoke FilterLSF2LSF22016-07-20
05034480314802Pall-Aquasafe™ Detachable Shower RoseAQROSEAAQROSEA2016-07-20
05034480315106Pall625418562541852015-10-21
05034480315502Pall QPoint® Filter CapsuleQJ22AQJ22A2017-12-20
05034480315519Pall QPoint® Filter CapsuleQJ212AQJ212A2017-12-20
05034480315526Pall QPoint® Filter CapsuleQR212AQR212A2017-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760279733234Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733265Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733296Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733333Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733371Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733401Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733449Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733470Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
03760279733500Disposable water filter Filt'RayAQUATOOLSNHV2024-05-15
00896241002091DSU-H Quick Connect (Polypropylene)NEPHROS, INC.NHV2022-03-11
00896241002107DSU-H Thread (Polyproplyene)NEPHROS, INC.NHV2022-03-11
10896241002098DSU-H Quick Connect (Polypropylene)NEPHROS, INC.NHV2022-03-11
10896241002104DSU-H Thread (Polyproplyene)NEPHROS, INC.NHV2022-03-11
03760279730011Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730073Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730080Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730103Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730110Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731100Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731117Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731124Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731131Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731148Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731155Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731162Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731179Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731186Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279731193Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730004Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05
03760279730400Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05