Moda-flx Hemodialysis System N/A

GUDID 00860008016928

Haemodialysis system, institutional/home-use

Primary Device ID	00860008016928
NIH Device Record Key	c5d0202d-da6f-46e5-b3a7-ac1a93041e76
Commercial Distribution Status	In Commercial Distribution
Brand Name	Moda-flx Hemodialysis System
Version Model Number	101747-001
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860008016928 [Primary]
GS1	10860008016925 [Package] Package: [6 Units] In Commercial Distribution

KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System

Steralize Prior To Use	false
Device Is Sterile	true

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