PureClarity™

Primary DI
00810000521647
Brand
PureClarity™
Company
PARKELL, INC.
Model
D718
Catalog number
D718
Device description
PureClarity™ Purification Filter - Installation Kit
Published
2024-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JRSPurifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRSPurifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810000521647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810000521647008100005216478100005216470810000521647

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
6312491134customerservice@parkell.com

Regulatory Flags#

DUNS number
009900424
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M595S367UD1Epic®S367UDS367UD2016-09-23
M595S4130NAS413S4132016-09-23
00810000529568TotalBond®S413S4132018-11-23
00810000522729GentleCLEAN™DSG30GCPDSG30GCP2018-11-02
10810000527554Parkell®S276S2762018-10-19
M595S3930NAS393S3932016-09-23
M595S3940NAS394S3942016-09-23
M595S3950C&B METABOND®S395S3952016-09-23
00810000529070C&B METABOND®S394S3942018-11-23
00810000529193C&B METABOND®S393S3932018-11-23
00810000529209C&B METABOND®S395S3952018-11-23
00810000525294SmarTemp®S338S3382018-10-26
1081000052669420/20™S575S5752025-09-26
00810000525782HyperFIL®S235SPS235SP2025-09-26
00810000528271TriPhasix™S408S4082025-09-26
0081000052669720/20™S575S5752025-09-26
M595D6750Aurora™D675D6752016-09-24
00810000520053Parkell®D675D6752018-11-16
00810000522934DuraTip®DURA30-PSLDURA30-PSL2025-07-18
00810000522941DuraTip®DURA30-PSRDURA30-PSR2025-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G212WS20301WaterSoftIbt Scientific LLCJRS2025-12-12
G212WS21350WaterSoft 0-30Ibt Scientific LLCJRS2025-12-12
00810000521579PureClarity™PARKELL, INC.JRS2024-12-13
00850006962068HistoSonicsHistosonics, Inc.JRS2024-07-29
00850006962075HistoSonicsHistosonics, Inc.JRS2024-07-29
00380740138783AlinityAbbott GmbHJRS2023-11-16
00858293006342Water Hardness Test StripREPROCESSING PRODUCTS CORPORATIONJRS2019-06-18
10858293006349Water Hardness Test StripREPROCESSING PRODUCTS CORPORATIONJRS2019-06-18