VersiHD with GuideMe software

GUDID M535NX100010E0

Haemodialysis system, institutional/home-use

Primary Device ID	M535NX100010E0
NIH Device Record Key	348aafad-93ae-481b-8ab9-b437cc2fd2a4
Commercial Distribution Status	In Commercial Distribution
Brand Name	VersiHD with GuideMe software
Version Model Number	NX1000-10-E
Company DUNS	088013219
Company Name	NXSTAGE MEDICAL, 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

Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -25 Degrees Celsius and 70 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	M535NX100010E0 [Primary]

KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System

Steralize Prior To Use	false
Device Is Sterile	false