AURA

Primary DI
G460DG1010
Brand
AURA
Company
Branchpoint & Aura Development LLC
Model
DG101
Device description
AURA™ Data Receiver Pack
Published
2024-01-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDevice, Monitoring, Intracranial Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172209000AURA ICP MONITORING SYSTEMBranchpoint Technologies, Inc.2018-05-18GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G460DG1010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal105 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
909-278-7062info@branchpointmed.com

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011785293AURASP104SP1042024-03-25
00860011785286AURASP103SP1032024-03-25
00860011785200AURASP101SP1012024-03-25
00860011785217AURATK101TK1012024-03-25
00860011785224AURADG101DG1012024-03-25
00860011785231AURATX101TX1012024-03-25
00860011785248AURATA101TA1012024-03-25
00860011785255AURATB101TB1012024-03-25
00860011785262AURATC101TC1012024-03-25
00860011785279AURASP102SP1022024-03-25
G460SP1010AURASP101SP1012024-01-09
G460TA1010AURATA1012024-01-09
G460TB1010AURATB1012024-01-09
G460TC1010AURATC1012024-01-09
G460TK1010AURATK1012024-01-09
G460TX1010AURATX1012024-01-09

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20763000467344NAMEDTRONIC PS MEDICAL, INC.GWM2024-03-01
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20763000467382NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
20763000467399NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
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00763000431259BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
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00763000529369BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000572877BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-25
00850013266203IRRAflow Tube SetClearpoint Neuro, Inc.GWM2023-11-02
00763000624774Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000624781Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
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00763000428723Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428747Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428754Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428761Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428778Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000431273Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-13
20763000431307N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395971Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395988N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406004Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406011Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07