Moda-flx Hemodialysis System N/A

GUDID 00860008016966

Haemodialysis system, institutional/home-use

Primary Device ID	00860008016966
NIH Device Record Key	8c7733aa-8b56-4119-b85a-905064a4b07a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Moda-flx Hemodialysis System
Version Model Number	102492-001
Catalog Number	N/A
Company DUNS	105303391
Company Name	Diality Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860008016966 [Primary]

KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System

Steralize Prior To Use	false
Device Is Sterile	false

10860008016970	Moda-flx Disposable PAA Straw
00860008016966	Moda-flx Cart
00860008016959	Moda-flx Disposable Acid Straws
00860008016935	Moda-flx Disposable Bicarbonate Straws
00860008016928	Moda-flx Disposable Cartridge
00860008016911	Moda-flx Hemodialysis Delivery (HD) device
00860008016904	Moda-flx Dialysate Generator (DG) device