Maky 21.1

Basic Information

• Brand Name: Maky 21.1
• Primary DI: 00898021000037
• Version / Model: 21.1
• Catalog Number: MAKY21.1
• Company Name: Angelini Pharma Inc.
• Labeler DUNS: 078843940
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-29
• Public Version: 4
• Public Version Date: 2023-02-15
• Public Version Status: Update
• Public Device Record Key: 615b7242-ee00-4a02-aeec-5ed38c40b857

Device Description

Dialyzer reprocessing machine.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
LIF	Dialyzer Reprocessing System	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33888	Haemodialysis dialyser reprocessing system	An assembly of mains electricity (AC-powered) devices designed to clean and disinfect haemodialysis dialyzers after each use so that they can be reused, usually by the same patient. It typically performs a cycle that includes rinsing the dialyser with water/cleaning agent [e.g., hydrogen peroxide (H2O2)]; reverse ultrafiltration cleaning; disinfection or re-sterilization (e.g., with formaldehyde); labelling; and performance testing (e.g., volume, pressure). The complete cycle may be performed on one dialyser at a time or several at once (i.e., a single- or multiple-station system). The system may include computing capabilities or be attached to a personal computer for operation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00898021000037	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K024076	000