FDA.reportPublic FDA data

Alinity

Primary DI
00380740138783
Brand
Alinity
Company
Abbott GmbH
Model
09P7101
Catalog number
09P7101
Device description
Alinity h-series WATER PURIFICATION SYSTEM
Published
2023-11-16
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
00380740138783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740138783003807401387833807401387830380740138783

GMDN Terms#

Term, Definition table
TermDefinition
Deionization water purification systemAn assembly of mains electricity (AC-powered) devices that includes ion exchange columns designed to remove unwanted chemical contaminants from water. This system purifies water principally by removing negative and positive ions of minerals (e.g., sodium, calcium, iron, copper) using filtration through a combination of anionic and cationic resins (also known as demineralization); it facilitates the production of "soft" water.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

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
00810000521647PureClarity™PARKELL, INC.JRS2024-12-13
00850006962068HistoSonicsHistosonics, Inc.JRS2024-07-29
00850006962075HistoSonicsHistosonics, Inc.JRS2024-07-29
00858293006342Water Hardness Test StripREPROCESSING PRODUCTS CORPORATIONJRS2019-06-18
10858293006349Water Hardness Test StripREPROCESSING PRODUCTS CORPORATIONJRS2019-06-18