Compumedics Somte 8012-0008-05

GUDID 09342451001757

Assembly, Somte PIB , Compumedics

COMPUMEDICS LIMITED

Polysomnograph
Primary Device ID09342451001757
NIH Device Record Keyfd2bec26-5587-4fb7-b1ee-e5ec035a8958
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompumedics Somte
Version Model NumberSomte
Catalog Number8012-0008-05
Company DUNS753750967
Company NameCOMPUMEDICS LIMITED
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+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS109342451001757 [Primary]

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 Number4
Public Version Date2021-04-27
Device Publish Date2016-11-17

On-Brand Devices [Compumedics Somte]

09342451001764Somte Compumedics Sensor Kit
09342451001757Assembly, Somte PIB , Compumedics
09342451001740Assembly - Somte Recording Unit Compumedics
09342451001733Somte Recording System Compumedics, no Software
09342451001498SomtePSG THOR cable (Yellow)
09342451001481SomtePSG ABDO cable (Blue)
09342451001474Somte PSG v2 lead kit
09342451001382Somte PSG v2 Assembly
09342451001368Somte PSG v2 System, No software

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