AccessGUDID - DEVICE: AURA (G460DG1010)

GUDID

Device Identifier (DI) Information

Brand Name: AURA
Version or Model: DG101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Branchpoint & Aura Development LLC

Primary DI Number: G460DG1010
Issuing Agency: HIBCC
Commercial Distribution End Date: February 28, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 063237649 *Terms of Use

Device Description: AURA™ Data Receiver Pack

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32547	Medical networking interface unit	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	Device, Monitoring, Intracranial Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172209	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 105 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ff80e01-24fd-46ef-aa90-e6e19abe651b
Public Version Date: February 29, 2024
Public Version Number: 2
DI Record Publish Date: January 09, 2024