Watch-PAT300 AS2110700

GUDID 07290109222417

Watch-PAT300 Device

ITAMAR MEDICAL LTD

Polysomnograph
Primary Device ID07290109222417
NIH Device Record Key3abd479d-6d99-44ad-ad67-15472d86bd6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameWatch-PAT300
Version Model NumberWatch-PAT300
Catalog NumberAS2110700
Company DUNS531857076
Company NameITAMAR MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97246177000
Emailinfo@itamar-medical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109222400 [Package]
Package: box [1 Units]
In Commercial Distribution
GS107290109222417 [Primary]
GS107290109222448 [Package]
Package: box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNRVentilatory Effort Recorder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-29
Device Publish Date2019-03-27

On-Brand Devices [Watch-PAT300]

07290109222417Watch-PAT300 Device
07290109222462Watch-PAT300 Device
07290109222486Watch-PAT300 Device

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