Disposable Water Filter FILTRAY 2G

Primary DI
03760279730400
Brand
Disposable Water Filter FILTRAY 2G
Company
AQUATOOLS
Model
AT030713
Catalog number
AT030713
Device description
2 Month - Disposable Shower Head Water Filter - Sterile
Published
2021-11-05
Public version status
New
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
K191563000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191563000FILTRAY 2G Disposable Water FiltersAqua-Tools2019-10-25NHV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760279730400PackageGS110In Commercial Distribution
03760279730011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760279730400037602797304003760279730400
03760279730011037602797300113760279730011

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
+33139750220md.regaffairs@aqua-tools.com

Regulatory Flags#

DUNS number
261121550
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760279733234Disposable water filter Filt'RayAT20150US2024-05-15
03760279733265Disposable water filter Filt'RayAT20151US2024-05-15
03760279733296Disposable water filter Filt'RayAT20161US2024-05-15
03760279733333Disposable water filter Filt'RayAT20250US2024-05-15
03760279733371Disposable water filter Filt'RayAT20251US2024-05-15
03760279733401Disposable water filter Filt'RayAT20261US2024-05-15
03760279733449Disposable water filter Filt'RayAT20350US2024-05-15
03760279733470Disposable water filter Filt'RayAT20351US2024-05-15
03760279733500Disposable water filter Filt'RayAT20361US2024-05-15
03760279730011Disposable Water Filter FILTRAY 2GAT030713AT0307132021-11-05
03760279730073Disposable Water Filter FILTRAY 2GAT030718AT0307182021-11-05
03760279730080Disposable Water Filter FILTRAY 2GAT030720AT0307202021-11-05
03760279730103Disposable Water Filter FILTRAY 2GAT030717AT0307172021-11-05
03760279730110Disposable Water Filter FILTRAY 2GAT030719AT0307192021-11-05
03760279731100Disposable Water Filter FILTRAY 2GAT030750AT0307502021-11-05
03760279731117Disposable Water Filter FILTRAY 2GAT030748AT0307482021-11-05
03760279731124Disposable Water Filter FILTRAY 2GAT030749AT0307492021-11-05
03760279731131Disposable Water Filter FILTRAY 2GAT030747AT0307472021-11-05
03760279731148Disposable Water Filter FILTRAY 2GAT030780AT0307802021-11-05
03760279731155Disposable Water Filter FILTRAY 2GAT030779AT0307792021-11-05

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
03760279730431Disposable Water Filter FILTRAY 2GAQUATOOLSNHV2021-11-05