Compumedics Somfit D 9037-0022-00

GUDID 09342451007063

Somfit D (Single)

COMPUMEDICS LIMITED

Polysomnograph
Primary Device ID09342451007063
NIH Device Record Key4f5c851b-a269-41c1-9332-830180012997
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompumedics Somfit D
Version Model NumberSomfit D
Catalog Number9037-0022-00
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS109342451007063 [Primary]
GS109342451007124 [Package]
Package: [10 Units]
In Commercial Distribution
GS109342451007131 [Package]
Package: [50 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-20
Device Publish Date2026-03-12

Devices Manufactured by COMPUMEDICS LIMITED

09342451002433 - Compumedics Curry2026-03-20 CURRY 9
09342451002655 - Compumedics Somfit2026-03-20 Somfit Main Unit
09342451002662 - Compumedics Somfit2026-03-20 Somfit Charger
09342451002747 - Compumedics Falcon2026-03-20 Falcon HST Main Unit
09342451002754 - Compumedics Falcon2026-03-20 Falcon HST Cradle
09342451002785 - Compumedics Falcon2026-03-20 Falcon HST System
09342451002822 - Compumedics Somfit2026-03-20 Somfit System Americas
09342451002860 - Compumedics Somfit2026-03-20 Somfit System Americas (7 electrodes)

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