SleepmateUARS Disposable Sensors 816400-000/10

GUDID 05707480041909

Polysomnograph

Primary Device ID	05707480041909
NIH Device Record Key	ec8c3cb4-cefa-4fb3-9e29-83776dd5b73e
Commercial Distribution Status	In Commercial Distribution
Brand Name	SleepmateUARS Disposable Sensors
Version Model Number	816400-000/10
Catalog Number	816400-000/10
Company DUNS	305682023
Company Name	Ambu A/S
Device Count	10
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	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Phone	+14107686464
Email	Purchase_orders@ambuUSA.com

Device Issuing Agency	Device ID
GS1	05707480041909 [Primary]
GS1	05707480134014 [Unit of Use]

BZQ	Monitor, breathing frequency

Steralize Prior To Use	false
Device Is Sterile	false