AccuSom

GUDID 00860512000215

Home-use sleep apnoea recording system

Primary Device ID	00860512000215
NIH Device Record Key	5d6bd130-361a-4bd3-9bc1-0fd07ff5a79e
Commercial Distribution Status	In Commercial Distribution
Brand Name	AccuSom
Version Model Number	NS2010
Company DUNS	808379150
Company Name	NOVASOM, 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	true
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
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	00860512000215 [Primary]

Steralize Prior To Use	false
Device Is Sterile	false

00860512000208	Sleep apnea diagnosic device
00860512000246	Chain of Custody Disposable Sensors
00860512000239	Device box
00860512000222	Breath Sensor
00860512000215	Chain of Custody Patient Interface Dongle
00860512000253	Home Sleep Test Device v3
00860512000291	Home Sleep Test Kit v3
00860512000277	Breath Sensor v3
00860512000260	Chest Sensor v3

Mark Image Registration \| Serial	Company Trademark Application Date
ACCUSOM 85118635 4147299 Live/Registered	NOVASOM, INC. 2010-08-30