Watch-PAT200U US2150502

GUDID 07290109222899

Polysomnograph

Primary Device ID	07290109222899
NIH Device Record Key	2fa5d8b8-0b10-4f3a-bac0-f0ad9ee288a1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Watch-PAT200U
Version Model Number	Watch-PAT200U
Catalog Number	US2150502
Company DUNS	531857076
Company Name	ITAMAR MEDICAL LTD
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

Phone	+97246177000
Email	info@itamar-medical.com

Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 68.95 KiloPascal and 103.42 KiloPascal
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 68.95 KiloPascal and 103.42 KiloPascal

Device Issuing Agency	Device ID
GS1	07290109222493 [Package] Package: box [1 Units] In Commercial Distribution
GS1	07290109222899 [Primary]

MNR	Ventilatory Effort Recorder

Steralize Prior To Use	false
Device Is Sterile	false