Home GUDID G460TX1010 AURA
Primary DI G460TX1010
Brand AURA
Company Branchpoint & Aura Development LLC
Model TX101
Device description AURA™ Monitor
Published 2024-01-09
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name GWM Device, Monitoring, Intracranial Pressure
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWM Device, Monitoring, Intracranial Pressure Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G460TX1010 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Intracranial pressure monitor An electrically-powered device intended for intermittent or continuous measurement and display of intracranial pressure (ICP). It is used in conjunction with an invasive intracranial device (e.g., intracerebral sensor catheter) that transmits electrical signals via connected cables or pressure signals via tubing (e.g., via the air pouch method), or either telemetrically. It may include an alarm designed to alert clinical staff to an elevated ICP and may also produce a strip-chart recording or display of the ICP waveform that enables interpretation of long-term ICP trends.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 50 KiloPascal 105 KiloPascal Storage Environment Humidity 20 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 063237649 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07908398200008 Braincare BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SA GWM 2026-05-08 00850013266272 IRRAflow Cranial Access Bolt Clearpoint Neuro, Inc. GWM 2025-07-24 00763000281243 Exacta Pole Clamp with laser level MEDTRONIC PS MEDICAL, INC. GWM 2025-02-17 00763000281229 Exacta Pole Clamp with laser level MEDTRONIC PS MEDICAL, INC. GWM 2025-02-16 00763000467401 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-06-01 00763000406073 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-03-31 20763000467344 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-03-01 20763000467351 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 20763000467382 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 20763000467399 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000406080 NA MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000431259 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000529307 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000529369 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-26 00763000572877 Becker MEDTRONIC PS MEDICAL, INC. GWM 2024-02-25 00850013266203 IRRAflow Tube Set Clearpoint Neuro, Inc. GWM 2023-11-02 00763000624774 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000624781 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000624798 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2022-03-10 00763000428723 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428747 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428754 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428761 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000428778 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-03-07 00763000431273 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-13 20763000431307 N/A MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000395971 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000395988 N/A MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000406004 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07 00763000406011 Duet® MEDTRONIC PS MEDICAL, INC. GWM 2021-02-07
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