EnsoSleep

GUDID 00864458000407

Sleep disorder interpretive software

Primary Device ID	00864458000407
NIH Device Record Key	7eac5f4c-f808-4474-8bd5-9b9dd4055e6d
Commercial Distribution Status	In Commercial Distribution
Brand Name	EnsoSleep
Version Model Number	01.1
Company DUNS	080743964
Company Name	ENSODATA, 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	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00864458000407 [Primary]

OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Steralize Prior To Use	false
Device Is Sterile	false

00864458000407	Automated sleep scoring software.
00864458000414	7.0
00864458000476	Automated sleep study scoring and report generation by EnsoData