Compumedics Falcon 8036-0003-01

GUDID 09342451002754

Falcon HST Cradle

COMPUMEDICS LIMITED

Polysomnograph
Primary Device ID09342451002754
NIH Device Record Key96244fff-c23e-4eda-9ce5-5605257b08ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompumedics Falcon
Version Model NumberFalcon HST
Catalog Number8036-0003-01
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

Device Identifiers

Device Issuing AgencyDevice ID
GS109342451002754 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-20
Device Publish Date2026-03-12

On-Brand Devices [Compumedics Falcon]

09342451002785Falcon HST System
09342451002754Falcon HST Cradle
09342451002747Falcon HST Main Unit

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