FDA.reportPublic FDA data

Pall-Aquasafe™ Detachable Shower Rose

Primary DI
05034480314802
Brand
Pall-Aquasafe™ Detachable Shower Rose
Company
Pall International Sàrl
Model
AQROSEA
Catalog number
AQROSEA
Device description
Detachable Shower Rose - For use with Pall-Aquasafe Water Filter - Faucet (AQ31F1SA) for 31 day use
Published
2016-07-20
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
K153434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153434000Pall-Aquasafe Water FilterPall International Sarl2016-06-10NHV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35034480314803PackageGS125In Commercial Distribution
05034480314802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3503448031480335034480314803
05034480314802050344803148025034480314802

GMDN Terms#

Term, Definition table
TermDefinition
Wound irrigation nozzleA 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, and is also typically intended to assist in protecting the filter from retrograde contamination; it is not primarily intended for intraoperative use. It is typically designed as a moulded nozzle (e.g., shower rose). This is a single-use device.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
485050483
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
05034480315106Pall625418562541852015-10-21
05034480315502Pall QPoint® Filter CapsuleQJ22AQJ22A2017-12-20
05034480315519Pall QPoint® Filter CapsuleQJ212AQJ212A2017-12-20
05034480315526Pall QPoint® Filter CapsuleQR212AQR212A2017-12-20
05034480315533Pall QPoint® Filter CapsuleQR22AQR22A2017-12-20

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