| Primary Device ID | G460TB1010 | 
| NIH Device Record Key | 02837fc9-b675-4250-b264-42f581b820c4 | 
| Commercial Distribution Discontinuation | 2024-02-28 | 
| Commercial Distribution Status | Not in Commercial Distribution | 
| Brand Name | AURA | 
| Version Model Number | TB101 | 
| Company DUNS | 063237649 | 
| Company Name | Branchpoint & Aura Development LLC | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | true | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | G460TB1010 [Primary] | 
| GWM | Device, Monitoring, Intracranial Pressure | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2024-02-29 | 
| Device Publish Date | 2024-01-09 | 
| G460TX1010 | AURA™ Monitor | 
| G460TK1010 | AURA™ Monitor Pack | 
| G460TC1010 | AURA™ Battery Charger | 
| G460TB1010 | AURA™ Battery | 
| G460TA1010 | AURA™ Antenna | 
| G460SP1010 | AURA™ Sensor Tray | 
| G460DG1010 | AURA™ Data Receiver Pack | 
| 00860011785293 | AURA™ Holster | 
| 00860011785286 | AURA™ Sensor & Holster | 
| 00860011785279 | AURA™ Sensor | 
| 00860011785262 | AURA™ Battery Charger | 
| 00860011785255 | AURA™ Battery | 
| 00860011785248 | AURA™ Antenna | 
| 00860011785231 | AURA™ Monitor | 
| 00860011785224 | AURA™ Data Receiver Pack | 
| 00860011785217 | AURA™ Monitor Pack | 
| 00860011785200 | AURA™ Sensor Tray | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  AURA  98892333  not registered Live/Pending | CRESCENT DESIGNS LLC 2024-12-09 | 
|  AURA  98859703  not registered Live/Pending | Mora, Luis Alberto 2024-11-18 | 
|  AURA  98784788  not registered Live/Pending | Day Moon Designs Inc. 2024-10-03 | 
|  AURA  98647202  not registered Live/Pending | Aura Dwellings & Hospitality, LLC 2024-07-13 | 
|  AURA  98588095  not registered Live/Pending | Malik, Shariq A 2024-06-06 | 
|  AURA  98542618  not registered Live/Pending | AMBER THERAPEUTICS LTD 2024-05-09 | 
|  AURA  98508847  not registered Live/Pending | Curant Health Georgia 2024-04-19 | 
|  AURA  98506483  not registered Live/Pending | KHKA Playgrounds LLC 2024-04-18 | 
|  AURA  98439870  not registered Live/Pending | Hearst Magazine Media, Inc. 2024-03-08 | 
|  AURA  98371991  not registered Live/Pending | Rasheed Rasul 2024-01-23 | 
|  AURA  98302837  not registered Live/Pending | College Park Industries, Inc. 2023-12-07 | 
|  AURA  98300508  not registered Live/Pending | E. & J. Gallo Winery 2023-12-05 |