PRISMAFLEX SET M100

Basic Information

• Brand Name: PRISMAFLEX SET M100
• Primary DI: 07332414201340
• Version / Model: 106697MDR
• Catalog Number: 106697MDR
• Company Name: Vantive Health GmbH
• Labeler DUNS: 480723888
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-27
• Public Version: 1
• Public Version Date: 2026-04-06
• Public Version Status: New
• Public Device Record Key: 73c9d5b1-fca5-438b-8c8e-d805858755cb

Device Description

The Prismaflex M100 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDI	Dialyzer, high permeability with or without sealed dialysate system	Gastroenterology, Urology	876.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44601	Haemofilter	A filter used in the process of haemofiltration, a treatment whereby extracorporeal blood is slowly and continuously passed through a system to allow for the removal of toxins and/or the replacement of electrolytes. The device functions with dialysate solution for the transfer of substances by diffusion and convection. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	57332414201345	GS1	Case	4	In Commercial Distribution
Primary	07332414201340	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041005	000

Device Sizes

Type	Value	Unit	Text
Width	22	Centimeter
Weight	814	Gram
Height	9	Centimeter
Length	27	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the Prismaflex set in a dry place, between 0° C (32° F) and 30° C (86° F).