Alinity

Basic Information

• Brand Name: Alinity
• Primary DI: 00380740138783
• Version / Model: 09P7101
• Catalog Number: 09P7101
• Company Name: Abbott GmbH
• Labeler DUNS: 315786293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-16
• Public Version: 1
• Public Version Date: 2023-11-24
• Public Version Status: New
• Public Device Record Key: fc4fe754-f70e-434e-955f-7c4ac3e0230c

Device Description

Alinity h-series WATER PURIFICATION SYSTEM

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JRS	PURIFIER, WATER (ABSORPTION, DEIONIZATION, MEMBRANE FILTER, REVERSE OSMOSIS)	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14435	Deionization water purification system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380740138783	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]